Trial Outcomes & Findings for Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy (NCT NCT01499849)
NCT ID: NCT01499849
Last Updated: 2016-05-19
Results Overview
The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (\>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (\>24 to 120 hours).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
532 participants
Primary outcome timeframe
>24 to 120 hours post chemotherapy
Results posted on
2016-05-19
Participant Flow
Participant milestones
| Measure |
Rolapitant + Granisetron + Dexamethasone
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
|---|---|---|
|
Overall Study
STARTED
|
266
|
266
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
224
|
226
|
Reasons for withdrawal
| Measure |
Rolapitant + Granisetron + Dexamethasone
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
|---|---|---|
|
Overall Study
Adverse Event
|
28
|
32
|
|
Overall Study
Chemo completed or Change in Therapy
|
70
|
67
|
|
Overall Study
Withdrawal by Subject
|
43
|
43
|
|
Overall Study
Death
|
5
|
7
|
|
Overall Study
Disease Progression
|
11
|
10
|
|
Overall Study
Protocol Violation
|
11
|
11
|
|
Overall Study
Physician Decision
|
20
|
19
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
|
Overall Study
Other Reasons
|
27
|
30
|
Baseline Characteristics
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
Baseline characteristics by cohort
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=264 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
n=262 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Total
n=526 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 11.15 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
231 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
459 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
178 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
357 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: >24 to 120 hours post chemotherapyPopulation: MITT
The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (\>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (\>24 to 120 hours).
Outcome measures
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=264 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
n=262 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
|---|---|---|
|
No Emetic Episodes and No Rescue Medication
|
72.7 percentage of participants
Interval 66.9 to 78.0
|
58.4 percentage of participants
Interval 52.2 to 64.4
|
SECONDARY outcome
Timeframe: 0 to 24 hoursPopulation: MITT
To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours)phase of CINV
Outcome measures
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=264 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
n=262 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
|---|---|---|
|
Acute Phase Response
|
83.7 percentage of participants
Interval 78.7 to 88.0
|
73.7 percentage of participants
Interval 67.9 to 78.9
|
SECONDARY outcome
Timeframe: 0 to 120 hoursPopulation: MITT
To determine the effect of rolapitant on complete response rates in the overall (0 to 120 hours) phase of CINV.
Outcome measures
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=264 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
n=262 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
|---|---|---|
|
Overall Response Rate
|
70.1 percentage of participants
Interval 64.2 to 75.5
|
56.5 percentage of participants
Interval 50.2 to 62.6
|
Adverse Events
Rolapitant + Granisetron + Dexamethasone
Serious events: 37 serious events
Other events: 187 other events
Deaths: 0 deaths
Placebo + Granisetron + Dexamethasone
Serious events: 54 serious events
Other events: 198 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=263 participants at risk
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
n=263 participants at risk
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.1%
3/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Cardiac disorders
Cardiac Failure
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Cardiac disorders
Cardiomyopathy
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Ileus
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Impaired Gastric Empyting
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
1.9%
5/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Asthenia
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Death
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
1.1%
3/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Disease Progression
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Fatigue
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
General Physical Health Deterioration
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Malaise
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Sudden Death
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Bronchitis Bacterial
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Encephalitis Herpes
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Endocarditis
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Infective Exacerabation of Bronchiectasis
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Lung Abscess
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Pneumonia
|
1.9%
5/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Sepsis
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Infections and infestations
Septic Shock
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
1.9%
5/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Cancer
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Nervous system disorders
Convulsion
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Nervous system disorders
Syncope
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
1.1%
3/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural Fistula
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
1.5%
4/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.76%
2/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Vascular disorders
Embolism
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Vascular disorders
Hypotension
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.00%
0/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
0.38%
1/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
Other adverse events
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=263 participants at risk
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
Placebo + Granisetron + Dexamethasone
n=263 participants at risk
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy
* Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2-4
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.6%
28/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
12.2%
32/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.8%
18/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
5.3%
14/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
33/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
8.7%
23/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.1%
16/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
4.6%
12/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Constipation
|
9.9%
26/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
11.0%
29/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
20/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
6.8%
18/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
18/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
3.0%
8/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
24/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
13.3%
35/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
16/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
5.3%
14/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Gastrointestinal disorders
vomiting
|
3.4%
9/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
8.4%
22/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Asthenia
|
13.3%
35/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
15.2%
40/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Fatigue
|
13.7%
36/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
11.4%
30/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
General disorders
Mucosal Inflammation
|
6.5%
17/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
7.2%
19/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.4%
30/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
13.7%
36/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
13/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
5.7%
15/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.1%
16/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
3.0%
8/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.4%
22/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
|
8.7%
23/263 • Up to 6 cycles of treatment (median number cycles=2; median duration of each cycle = 21-22 days)
Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
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Additional Information
Martin Huber, M.D., Senior Vice President and Chief Medical Officer
Tesaro
Phone: 781.257.2536
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place