Trial Outcomes & Findings for Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy (NCT NCT01500226)
NCT ID: NCT01500226
Last Updated: 2016-03-02
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 MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (\>24 to 120 hours).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1369 participants
Primary outcome timeframe
>24 to 120 hours post chemotherapy
Results posted on
2016-03-02
Participant Flow
Participant milestones
| Measure |
Rolapitant + Granisetron + Dexamethasone
* Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy.
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy.
|
Placebo + Granisetron + Dexamethasone
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
684
|
685
|
|
Overall Study
COMPLETED
|
185
|
191
|
|
Overall Study
NOT COMPLETED
|
499
|
494
|
Reasons for withdrawal
| Measure |
Rolapitant + Granisetron + Dexamethasone
* Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy.
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy.
|
Placebo + Granisetron + Dexamethasone
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
|---|---|---|
|
Overall Study
Adverse Event
|
31
|
38
|
|
Overall Study
Chemo Completed or Change in Therapy
|
235
|
237
|
|
Overall Study
Withdrawal by Subject
|
93
|
96
|
|
Overall Study
Death
|
12
|
4
|
|
Overall Study
Disease Progression
|
16
|
14
|
|
Overall Study
Protocol Violation
|
53
|
39
|
|
Overall Study
Physician Decision
|
17
|
15
|
|
Overall Study
Lack of Efficacy
|
14
|
30
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
|
Overall Study
Other Reasons
|
19
|
16
|
Baseline Characteristics
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
Baseline characteristics by cohort
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=666 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
Placebo + Granisetron + Dexamethasone
n=666 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
Total
n=1332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
531 Participants
n=5 Participants
|
536 Participants
n=7 Participants
|
1067 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
77 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
584 Participants
n=5 Participants
|
593 Participants
n=7 Participants
|
1177 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
92 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
508 Participants
n=5 Participants
|
512 Participants
n=7 Participants
|
1020 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
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 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 MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (\>24 to 120 hours).
Outcome measures
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=666 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
Placebo + Granisetron + Dexamethasone
n=666 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
|---|---|---|
|
No Emetic Episodes and No Rescue Medication
|
71.3 percentage of particpants
Interval 67.7 to 74.7
|
61.6 percentage of particpants
Interval 57.7 to 65.3
|
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=666 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
Placebo + Granisetron + Dexamethasone
n=666 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
|---|---|---|
|
Acute Phase Response
|
83.5 percentage of participants
Interval 80.4 to 86.2
|
80.3 percentage of participants
Interval 77.1 to 83.3
|
SECONDARY outcome
Timeframe: 0 to 120 hoursPopulation: MITT
To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.
Outcome measures
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=666 Participants
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
Placebo + Granisetron + Dexamethasone
n=666 Participants
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
|
|---|---|---|
|
Overall Response Rate
|
68.6 percentage of participants
Interval 64.9 to 72.1
|
57.8 percentage of participants
Interval 54.0 to 61.6
|
Adverse Events
Rolapitant + Granisetron + Dexamethasone
Serious events: 89 serious events
Other events: 540 other events
Deaths: 0 deaths
Placebo + Granisetron + Dexamethasone
Serious events: 103 serious events
Other events: 542 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=670 participants at risk
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
* 684 subjects were randomized to Rolapitant
* 670 of those randomized to Rolapitant received rolapitant in C1
* Safety = 670 Rolapitant
|
Placebo + Granisetron + Dexamethasone
n=674 participants at risk
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
* 685 subjects were randomized to control
* 674 of those who were randomized to control received control in C1
* Safety = 674 control
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.74%
5/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.1%
14/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
3.7%
25/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
7/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
1.9%
13/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Cardiac disorders
Atrial Fibrillation
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.59%
4/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Cardiac disorders
Cardiac Arrest
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Cardiac disorders
Palpitations
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Cardiac disorders
Pericarditis
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Ileus
|
0.45%
3/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Jejunal Perforation
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.45%
3/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Asthenia
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Chest Pain
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Disease Progression
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Fatigue
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Pyrexia
|
0.60%
4/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Appendicitis
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Catheter Site Infection
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Cellulitis
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Device Related Sepsis
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Diverticulitis
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Fungaemia
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Gastroenteritis
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Mucosal Infection
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Neutropenic Sepsis
|
0.60%
4/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Oral Fungal Infection
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Peridiverticular Abscess
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Pneumonia
|
0.60%
4/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.59%
4/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Postoperative Wound Infection
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Pyelonephritis Acute
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Sepsis
|
0.60%
4/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Urinary Tract Infection
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Investigations
Neutrophil Count Decreased
|
0.45%
3/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.59%
4/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.90%
6/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.59%
4/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Peritoneum
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Cerebral Haematoma
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Headache
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Hypoaesthesia
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Partial Seizures
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Posterior Reversible Encephalopathy Syndrome
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Psychiatric disorders
Mental Status Changes
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.75%
5/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.59%
4/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.45%
3/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.30%
2/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.30%
2/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Skin and subcutaneous tissue disorders
Skin Erosion
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.45%
3/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Vascular disorders
Embolism
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.00%
0/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Vascular disorders
Hypotension
|
0.15%
1/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.45%
3/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Vascular disorders
Thrombosis
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.00%
0/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
0.15%
1/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
Other adverse events
| Measure |
Rolapitant + Granisetron + Dexamethasone
n=670 participants at risk
* Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
* 684 subjects were randomized to Rolapitant
* 670 of those randomized to Rolapitant received rolapitant in C1
* Safety = 670 Rolapitant
|
Placebo + Granisetron + Dexamethasone
n=674 participants at risk
* Matching placebo 1-2 h before administration of chemotherapy
* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3
* Dexamethasone (20 mg orally) about 30 min before chemotherapy
* 685 subjects were randomized to control
* 674 of those who were randomized to control received control in C1
* Safety = 674 control
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
67/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
7.4%
50/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.5%
37/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
4.6%
31/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
96/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
12.5%
84/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.1%
34/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
4.6%
31/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Constipation
|
17.0%
114/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
20.5%
138/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
92/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
15.0%
101/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
46/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
6.2%
42/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Nausea
|
11.3%
76/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
14.4%
97/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Stomatitis
|
6.0%
40/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
6.8%
46/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
14/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
5.8%
39/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Asthenia
|
11.6%
78/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
11.6%
78/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Fatigue
|
26.7%
179/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
27.2%
183/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
General disorders
Mucosal Inflammation
|
6.1%
41/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
4.5%
30/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Infections and infestations
Urinary Tract Infection
|
8.5%
57/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
6.7%
45/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
13.7%
92/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
12.9%
87/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
25/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
5.5%
37/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
41/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
4.2%
28/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
25/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
5.0%
34/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.3%
42/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
5.9%
40/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Dizziness
|
10.3%
69/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
10.5%
71/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Dysgeusia
|
4.3%
29/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
5.6%
38/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Nervous system disorders
Headache
|
12.2%
82/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
16.2%
109/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Psychiatric disorders
Insomnia
|
4.8%
32/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
8.2%
55/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
35/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
5.5%
37/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.4%
157/670 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
25.5%
172/674 • Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
|
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