HEC: Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
Study Details
Study Description
Brief Summary
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC (≥60 mg/m2 of cisplatin-based chemotherapy). Study drug will be administered 1 - 2 hours prior to initiation of chemotherapy on Day 1. Granisetron and dexamethasone will be administered approximately 30 minutes before initiation of chemotherapy on Day 1,except in patients receiving taxanes as part of cisplatin-based chemotherapy. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting and will indicate the severity of nausea they experienced in each of the previous 24 hours in the NV Subject Diary prior to HEC administration through Day 6 in Cycle 1. Dexamethasone 8 mg twice daily (part of study regimen) on Days 2 through 4 is NOT considered rescue therapy. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of AEs, physical examinations including complete neurological assessment, vital signs,electrocardiograms (ECGs), and safety laboratory values including BUN andcreatinine. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles. The study will investigate the efficacy of rolapitant for the treatment of CINV during an initial chemotherapy cycle (Cycle 1).
Safety analyses will include data from Cycle 1 and from subsequent cycles. At the Screening Visit, blood samples may be collected and stored in this study and maybe analyzed for future biomarker research related to safety and efficacy. Analysis of these samples may include DNA, RNA, or protein markers. The biomarker blood samples will be stored for up to 2 years post study completion. In addition, PK samples will be collected from subjects enrolled in selected sites.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Placebo + Granisetron + Dexamethasone Day 1: Placebo + Granisetron (10 mcg/kg IV)+ dexamethasone (20 mg PO) Days 2-4: Dexamethasone (8 mg PO) will be administered orally BID. |
Drug: Granisetron
10 mcg/kg IV
Other Names:
Drug: Dexamethasone
20 mg PO and 8 mg PO
Other Names:
Drug: Placebo
(4 X 0 mg capsules) o mg PO
Other Names:
|
Experimental: Rolapitant Day 1: Rolapitant (200 mg PO) + Granisetron (10 mcg/kg IV)+ dexamethasone (20 mg PO) Days 2-4: Dexamethasone (8 mg PO) will be administered orally BID. |
Drug: Rolapitant
200 mg PO
Other Names:
Drug: Granisetron
10 mcg/kg IV
Other Names:
Drug: Dexamethasone
20 mg PO and 8 mg PO
Other Names:
|
Outcome Measures
Primary Outcome Measures
- No Emetic Episodes and No Rescue Medication [>24 to 120 hours post chemotherapy]
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 emesis and no rescue medication) in the delayed phase (>24 to 120 hours).
Secondary Outcome Measures
- Acute Phase Response [0 to 24 hours]
To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.
- Overall Response Rate [0 to 120 hours]
To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older, of either gender, and of any race
-
Has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2)
-
Karnofsky performance score of ≥60
-
Predicted life expectancy of ≥4 months
-
Adequate bone marrow, kidney, and liver function
Exclusion Criteria:
-
Contraindication to cisplatin, granisetron, or dexamethasone
-
Is pregnant or breast feeding
-
Has previously received cisplatin or subject is planning to receive multiple days of cisplatin in a single cycle
-
Has taken the following agents within the last 48 hours 5-HT3 antagonists,Phenothiazines,Benzamides,Domperidone,Cannabinoids,NK1 antagonist, Benzodiazepines
-
Scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 4 or above (Hesketh Scale) from Day 2 through Day 6, except on Day 1.
-
Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6
-
Has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes, pemetrexed)
-
Symptomatic primary or metastatic CNS disease.
-
Has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
-
Has vomited and/or has had dry heaves/retching within 24 hours prior to the start of cisplatin-based chemotherapy on Day 1 in Cycle 1.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | TESARO Inc | Waltham | Massachusetts | United States | 02451 |
Sponsors and Collaborators
- Tesaro, Inc.
Investigators
- Study Director: Dennis Vargo, MD, Tesaro, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TS-P04833
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone |
---|---|---|
Arm/Group Description | 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 | 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 |
Period Title: Overall Study | ||
STARTED | 278 | 277 |
COMPLETED | 61 | 53 |
NOT COMPLETED | 217 | 224 |
Baseline Characteristics
Arm/Group Title | Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone | Total |
---|---|---|---|
Arm/Group Description | 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 | 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 of all reporting groups |
Overall Participants | 271 | 273 | 544 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
58.5
(10.05)
|
58.5
(9.25)
|
58.5
(9.65)
|
Sex: Female, Male (Count of Participants) | |||
Female |
88
32.5%
|
87
31.9%
|
175
32.2%
|
Male |
183
67.5%
|
186
68.1%
|
369
67.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
36
13.3%
|
38
13.9%
|
74
13.6%
|
Not Hispanic or Latino |
235
86.7%
|
235
86.1%
|
470
86.4%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
2
0.7%
|
8
2.9%
|
10
1.8%
|
Asian |
34
12.5%
|
41
15%
|
75
13.8%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
2
0.7%
|
3
1.1%
|
5
0.9%
|
White |
226
83.4%
|
212
77.7%
|
438
80.5%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
7
2.6%
|
9
3.3%
|
16
2.9%
|
Outcome Measures
Title | No Emetic Episodes and No Rescue Medication |
---|---|
Description | 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 emesis and no rescue medication) in the delayed phase (>24 to 120 hours). |
Time Frame | >24 to 120 hours post chemotherapy |
Outcome Measure Data
Analysis Population Description |
---|
MITT |
Arm/Group Title | Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 271 | 273 |
Number (95% Confidence Interval) [percentage of participants] |
70.1
25.9%
|
61.9
22.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Rolapitant + Granisetron + Dexamethasone, Placebo + Granisetron + Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.043 |
Comments | To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint. | |
Method | Cochran-Mantel-Haenszel | |
Comments | Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures. | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% 1.0 to 2.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Acute Phase Response |
---|---|
Description | To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV. |
Time Frame | 0 to 24 hours |
Outcome Measure Data
Analysis Population Description |
---|
MITT |
Arm/Group Title | Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 271 | 273 |
Number (95% Confidence Interval) [percentage of participants] |
83.4
30.8%
|
79.5
29.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Rolapitant + Granisetron + Dexamethasone, Placebo + Granisetron + Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.233 |
Comments | To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant. | |
Method | Cochran-Mantel-Haenszel | |
Comments | Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures. | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% 0.8 to 2.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Overall Response Rate |
---|---|
Description | To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV. |
Time Frame | 0 to 120 hours |
Outcome Measure Data
Analysis Population Description |
---|
MITT |
Arm/Group Title | Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 271 | 273 |
Number (95% Confidence Interval) [percentage of participants] |
67.5
24.9%
|
60.4
22.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Rolapitant + Granisetron + Dexamethasone, Placebo + Granisetron + Dexamethasone |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.084 |
Comments | To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant. | |
Method | Cochran-Mantel-Haenszel | |
Comments | Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures. | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% 1.0 to 1.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | Up to 6 cycles (median number of cycles=3; median duration of each cycle = 21-23 days) of treatment | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone | ||
Arm/Group Description | 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 2-4 278 subjects were randomized to Rolapitant 272 of those randomized to Rolapitant received Rolapitant in C1 Safety = 272 Rolapitant | 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 2-4 277 subjects were randomized to control; 274 of those who were randomized to control received control in C1. Safety = 274 control | ||
All Cause Mortality |
||||
Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 80/272 (29.4%) | 65/274 (23.7%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 4/272 (1.5%) | 3/274 (1.1%) | ||
Febrile Neutropenia | 12/272 (4.4%) | 6/274 (2.2%) | ||
Leukopenia | 0/272 (0%) | 1/274 (0.4%) | ||
Neutropenia | 5/272 (1.8%) | 7/274 (2.6%) | ||
Pancytopenia | 1/272 (0.4%) | 1/274 (0.4%) | ||
Thrombocytopenia | 4/272 (1.5%) | 2/274 (0.7%) | ||
Cardiac disorders | ||||
Acute Myocardial Infarction | 1/272 (0.4%) | 0/274 (0%) | ||
Atrial Fibrillation | 3/272 (1.1%) | 0/274 (0%) | ||
Cardiac Arrest | 0/272 (0%) | 1/274 (0.4%) | ||
Cardiac Failure | 0/272 (0%) | 1/274 (0.4%) | ||
Gastrointestinal disorders | ||||
Abdominal Pain | 4/272 (1.5%) | 1/274 (0.4%) | ||
Aphagia | 1/272 (0.4%) | 0/274 (0%) | ||
Colitis | 0/272 (0%) | 1/274 (0.4%) | ||
Diarrhoea | 0/272 (0%) | 1/274 (0.4%) | ||
Enterocolitis | 0/272 (0%) | 1/274 (0.4%) | ||
Gastric Haemorrhage | 1/272 (0.4%) | 0/274 (0%) | ||
Gastric Ulcer Perforation | 1/272 (0.4%) | 0/274 (0%) | ||
Gastrointestinal Haemorrhage | 0/272 (0%) | 1/274 (0.4%) | ||
Haematochezia | 1/272 (0.4%) | 0/274 (0%) | ||
Ileus Paralytic | 1/272 (0.4%) | 0/274 (0%) | ||
Melaena | 0/272 (0%) | 1/274 (0.4%) | ||
Nausea | 1/272 (0.4%) | 0/274 (0%) | ||
Oesophagitis | 1/272 (0.4%) | 0/274 (0%) | ||
Stomatitis | 2/272 (0.7%) | 0/274 (0%) | ||
Upper Gastrointestinal Haemorrhage | 1/272 (0.4%) | 0/274 (0%) | ||
Vomiting | 2/272 (0.7%) | 2/274 (0.7%) | ||
General disorders | ||||
Asthenia | 5/272 (1.8%) | 5/274 (1.8%) | ||
Disease Progression | 3/272 (1.1%) | 2/274 (0.7%) | ||
Fatigue | 2/272 (0.7%) | 1/274 (0.4%) | ||
General Physical Health Deterioration | 0/272 (0%) | 1/274 (0.4%) | ||
Non-Cardiac Chest Pain | 2/272 (0.7%) | 0/274 (0%) | ||
Oedema | 1/272 (0.4%) | 0/274 (0%) | ||
Pyrexia | 0/272 (0%) | 1/274 (0.4%) | ||
Spinal Pain | 1/272 (0.4%) | 0/274 (0%) | ||
Sudden Death | 1/272 (0.4%) | 0/274 (0%) | ||
Hepatobiliary disorders | ||||
Biliary Colic | 0/272 (0%) | 1/274 (0.4%) | ||
Cholecystitis Acute | 1/272 (0.4%) | 0/274 (0%) | ||
Immune system disorders | ||||
Drug Hypersensitivity | 0/272 (0%) | 1/274 (0.4%) | ||
Infections and infestations | ||||
Device Related Infection | 0/272 (0%) | 1/274 (0.4%) | ||
Encephalitis Herpes | 0/272 (0%) | 1/274 (0.4%) | ||
Gastroenteritis | 1/272 (0.4%) | 0/274 (0%) | ||
Infection | 0/272 (0%) | 1/274 (0.4%) | ||
influenza | 0/272 (0%) | 1/274 (0.4%) | ||
Klebsiella Bacteraemia | 1/272 (0.4%) | 0/274 (0%) | ||
Lung Infection | 1/272 (0.4%) | 0/274 (0%) | ||
Neutropenic Sepsis | 1/272 (0.4%) | 0/274 (0%) | ||
Parotitis | 1/272 (0.4%) | 0/274 (0%) | ||
Pneumonia | 1/272 (0.4%) | 6/274 (2.2%) | ||
Pseudomonal Sepsis | 0/272 (0%) | 1/274 (0.4%) | ||
Respiratory Tract Infection | 3/272 (1.1%) | 0/274 (0%) | ||
Sepsis | 0/272 (0%) | 1/274 (0.4%) | ||
Urinary Tract Infection | 0/272 (0%) | 3/274 (1.1%) | ||
Injury, poisoning and procedural complications | ||||
Toxicity to Various Agents | 0/272 (0%) | 1/274 (0.4%) | ||
Investigations | ||||
Blood Creatinine Increased | 0/272 (0%) | 1/274 (0.4%) | ||
Neutrophil Count Decreased | 0/272 (0%) | 4/274 (1.5%) | ||
Metabolism and nutrition disorders | ||||
Decreased Appetite | 0/272 (0%) | 1/274 (0.4%) | ||
Dehydration | 3/272 (1.1%) | 2/274 (0.7%) | ||
Hyperglycaemia | 0/272 (0%) | 1/274 (0.4%) | ||
Hypoglycaemia | 1/272 (0.4%) | 0/274 (0%) | ||
Hyponatraemia | 1/272 (0.4%) | 0/274 (0%) | ||
Hypophagia | 0/272 (0%) | 1/274 (0.4%) | ||
Musculoskeletal and connective tissue disorders | ||||
Back Pain | 0/272 (0%) | 2/274 (0.7%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Leukoerythroblastosis | 0/272 (0%) | 1/274 (0.4%) | ||
Metastases to central nervous system | 1/272 (0.4%) | 0/274 (0%) | ||
Neoplasm Malignant | 0/272 (0%) | 1/274 (0.4%) | ||
Oral Neoplasm | 1/272 (0.4%) | 0/274 (0%) | ||
Tumour Pain | 1/272 (0.4%) | 0/274 (0%) | ||
Nervous system disorders | ||||
Cerebral Infarction | 1/272 (0.4%) | 0/274 (0%) | ||
Convulsion | 1/272 (0.4%) | 0/274 (0%) | ||
Dizziness | 1/272 (0.4%) | 0/274 (0%) | ||
Dysarthria | 1/272 (0.4%) | 0/274 (0%) | ||
Hepatic Encephalopathy | 1/272 (0.4%) | 0/274 (0%) | ||
Ischaemic Stroke | 1/272 (0.4%) | 0/274 (0%) | ||
Syncope | 1/272 (0.4%) | 0/274 (0%) | ||
Transient Ischaemic Attack | 0/272 (0%) | 1/274 (0.4%) | ||
Renal and urinary disorders | ||||
Dysuria | 0/272 (0%) | 1/274 (0.4%) | ||
Renal Failure | 2/272 (0.7%) | 1/274 (0.4%) | ||
Renal Failure Acute | 0/272 (0%) | 1/274 (0.4%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Acute Pulmonary Oedema | 0/272 (0%) | 1/274 (0.4%) | ||
Dyspnoea | 2/272 (0.7%) | 2/274 (0.7%) | ||
Haemoptysis | 1/272 (0.4%) | 0/274 (0%) | ||
Pneumothorax | 1/272 (0.4%) | 1/274 (0.4%) | ||
Pulmonary Embolism | 3/272 (1.1%) | 2/274 (0.7%) | ||
Vascular disorders | ||||
Arterial Occlusive Disease | 0/272 (0%) | 1/274 (0.4%) | ||
Axillary Vein Thrombosis | 1/272 (0.4%) | 0/274 (0%) | ||
Circulatory Collapse | 1/272 (0.4%) | 0/274 (0%) | ||
Deep Vein Thrombosis | 3/272 (1.1%) | 1/274 (0.4%) | ||
Haemorrhage | 0/272 (0%) | 1/274 (0.4%) | ||
Hypertension | 1/272 (0.4%) | 0/274 (0%) | ||
Hypotension | 3/272 (1.1%) | 0/274 (0%) | ||
Iliac Artery Occlusion | 0/272 (0%) | 1/274 (0.4%) | ||
Peripheral Arterial Occlusive Disease | 1/272 (0.4%) | 1/274 (0.4%) | ||
Subclavian Vein Thrombosis | 1/272 (0.4%) | 0/274 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Rolapitant + Granisetron + Dexamethasone | Placebo + Granisetron + Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 225/272 (82.7%) | 211/274 (77%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 30/272 (11%) | 16/274 (5.8%) | ||
Neutropenia | 39/272 (14.3%) | 32/274 (11.7%) | ||
Gastrointestinal disorders | ||||
Abdominal Pain | 14/272 (5.1%) | 9/274 (3.3%) | ||
Constipation | 37/272 (13.6%) | 40/274 (14.6%) | ||
Diarrhoea | 34/272 (12.5%) | 28/274 (10.2%) | ||
Dyspepsia | 10/272 (3.7%) | 14/274 (5.1%) | ||
Nausea | 32/272 (11.8%) | 35/274 (12.8%) | ||
Vomiting | 14/272 (5.1%) | 23/274 (8.4%) | ||
General disorders | ||||
Asthenia | 52/272 (19.1%) | 55/274 (20.1%) | ||
Fatigue | 21/272 (7.7%) | 28/274 (10.2%) | ||
Mucosal Inflammation | 21/272 (7.7%) | 21/274 (7.7%) | ||
Metabolism and nutrition disorders | ||||
Decreased Appetite | 39/272 (14.3%) | 35/274 (12.8%) | ||
Hypomagnesaemia | 16/272 (5.9%) | 16/274 (5.8%) | ||
Nervous system disorders | ||||
Headache | 15/272 (5.5%) | 12/274 (4.4%) | ||
Psychiatric disorders | ||||
Insomnia | 7/272 (2.6%) | 15/274 (5.5%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 11/272 (4%) | 14/274 (5.1%) | ||
Hiccups | 25/272 (9.2%) | 12/274 (4.4%) | ||
Skin and subcutaneous tissue disorders | ||||
Alopecia | 20/272 (7.4%) | 26/274 (9.5%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Martin Huber, M.D., Senior Vice President and Chief Medical Officer |
---|---|
Organization | Tesaro |
Phone | 862.228.2483 |
mhuber@tesarobio.com |
- TS-P04833