Trial Outcomes & Findings for Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects (NCT NCT00983957)
NCT ID: NCT00983957
Last Updated: 2015-10-16
Results Overview
Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Results posted on
2015-10-16
Participant Flow
A total of 47 participants were enrolled; 20 were treated. Reasons 27 participants were not treated: 21 no longer met study criteria, 2 withdrew consent, and 4 other reasons.
Participant milestones
| Measure |
Ortho Tri-Cyclen + Daclatasvir
Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
Treatment A
|
20
|
|
Overall Study
Treatment B
|
20
|
|
Overall Study
Treatment C
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Ortho Tri-Cyclen + Daclatasvir
Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Personal Reasons
|
1
|
Baseline Characteristics
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Baseline characteristics by cohort
| Measure |
Ortho Tri-Cyclen + Daclatasvir
n=20 Participants
Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 7.36 • n=99 Participants
|
|
Age, Customized
<= 45 years
|
20 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77Population: All participants who received the study drug.
Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol
|
118.53 picogram per millilitre (pg/mL)
Geometric Coefficient of Variation 34
|
134.70 picogram per millilitre (pg/mL)
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug.
Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol
|
959.37 pg*h/mL
Geometric Coefficient of Variation 38
|
994.40 pg*h/mL
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug
Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol
|
1.5 hours
Interval 1.0 to 2.0
|
1.5 hours
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug.
Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Maximum Observed Plasma Concentration of Norelgestromin
|
1.99 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 20
|
2.10 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug.
Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin
|
15.38 ng*h/mL
Geometric Coefficient of Variation 24
|
16.84 ng*h/mL
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug.
Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Time of Maximum Observed Plasma Concentration of Norelgestromin
|
1.3 hours
Interval 1.0 to 3.0
|
1.5 hours
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug.
Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography-mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Maximum Observed Plasma Concentration of Norgestrel
|
2674.69 pg/mL
Geometric Coefficient of Variation 32
|
2815.98 pg/mL
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug.
Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel
|
47258.35 pg*h/mL
Geometric Coefficient of Variation 38
|
51760.43 pg*h/mL
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77Population: All participants who received the study drug.
Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Time of Maximum Observed Plasma Concentration of Norgestrel
|
1.8 hours
Interval 1.0 to 3.0
|
2.0 hours
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drugPopulation: All participants who received at least one dose of study drug.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
SAE
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
AE Leading to Discontinuation
|
0 participants
|
1 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
Death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From start of treatment (Day 1) up to Day 78 or dischargePopulation: All participants who received at least one dose of study drug.
Laboratory marked abnormalities were defined as Hematocrit (low) as \<0.85\*Pre-treatment (PreRx), Hemoglobin (low) as \<0.85\*PreRx, Aspartate Aminotransferase (AST) (high) as \>1.25\*PreRx if PreRx \> upper limits of normal (ULN); \>1.25\*ULN if PreRx \<=ULN; \>1.25\*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx \<1; ≥2 if PreRx = Missing.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
Hemoglobin
|
1 participants
|
0 participants
|
|
Number of Participants With Laboratory Test Abnormalities
AST
|
1 participants
|
0 participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hematocrit
|
1 participants
|
0 participants
|
|
Number of Participants With Laboratory Test Abnormalities
Blood in Urine
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of dischargePopulation: All participants who received at least one dose of study drug.
Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, Day 1, Day 67, Day 77Population: All participants who received at least one dose of study drug.
The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).
Outcome measures
| Measure |
Ortho Tri-Cyclen
n=20 Participants
Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
|
Ortho Tri-Cyclen + Daclatasvir
n=18 Participants
Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|
|
Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters
|
0 participants
|
0 participants
|
Adverse Events
All Treated Participants
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Ortho Tri-Cyclen Days 1-28
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Ortho Tri-Cyclen Days 29-46
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ortho Tri-Cyclen Days 47-56
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Ortho Tri-Cyclen Days 57-67
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ortho Tri-Cyclen + Daclatasvir Days 68-77
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Treated Participants
n=20 participants at risk
Participants received sequentially Treatment A: Ortho Tri-Cyclen (OTC) fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 along with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
Ortho Tri-Cyclen Days 1-28
n=20 participants at risk
Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28.
|
Ortho Tri-Cyclen Days 29-46
n=20 participants at risk
Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 46.
|
Ortho Tri-Cyclen Days 47-56
n=20 participants at risk
Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 47 to 56.
|
Ortho Tri-Cyclen Days 57-67
n=18 participants at risk
Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67.
|
Ortho Tri-Cyclen + Daclatasvir Days 68-77
n=18 participants at risk
Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67 along with daclatasvir two tablets of 30-mg, orally, once daily from Day 68 to 77.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
4/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
16.7%
3/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Gastrointestinal disorders
Haematochezia
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Reproductive system and breast disorders
Metrorrhagia
|
30.0%
6/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
25.0%
5/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
16.7%
3/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
General disorders
Vessel puncture site haematoma
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
General disorders
Vessel puncture site pain
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Psychiatric disorders
Abnormal dreams
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
General disorders
Chest pain
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Eye disorders
Lacrimation increased
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
General disorders
Pain
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
11.1%
2/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
22.2%
4/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Eye disorders
Eye pain
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Nervous system disorders
Headache
|
45.0%
9/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
20.0%
4/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
30.0%
6/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
16.7%
3/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Reproductive system and breast disorders
Menstruation irregular
|
15.0%
3/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
2/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Injury, poisoning and procedural complications
Back injury
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
General disorders
Catheter site pain
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.6%
1/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
5.0%
1/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/20 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
0.00%
0/18 • From start of treatment (Day 1) up to Day 78 or discharge
On-Treatment Period
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb International Corporation
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER