Ages Eligible for Study: | 18 Years
to 130 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
-Patients with measurable disease and/or non-measurable or no evidence of disease
assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in
this study.
-Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or
suspected deleterious
- Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or
oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16
weeks of continuous platinum treatment and have no evidence of progression based
on investigator’s opinion.
-Patients who have received platinum as potentially curative treatment for a prior
cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer
are eligible provided at least 12 months have elapsed between the last dose of
platinum-based treatment and initiation of the platinum-based chemotherapy for
metastatic pancreas cancer.
Major Exclusion Criteria:
-gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg,
“Variants of uncertain clinical significance” or “Variant of unknown significance”
or “Variant, favour polymorphism” or “benign polymorphism” etc.)
-Progression of tumour between start of first line platinum based chemotherapy for
metastatic pancreas cancer and randomisation.
-Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle
1 Day 1 is not permitted.
-Exposure to an investigational product within 30 days or 5 half lives (whichever is
longer) prior to randomisation
-Any previous treatment with a PARP inhibitor, including Olaparib
Contacts
Contact:
AstraZeneca Clinical
Study Information Center
| 1-877-240-9479
| [email protected]
| |
Contact Backup:
AstraZeneca Cancer Study
Locator Service
| 1-877-400-4656
| [email protected]
| |
Sponsors and Collaborators
AstraZeneca
Myriad Genetics - BRCAnalysis test for FDA Premarket Approval (PMA)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Locations
Country | Location | Facility | Contact | Status | BE | Research Site | Antwerpen,
BE,
2020 | | Completed |
BE | Research Site | Brussel,
BE,
1070 | | Completed |
BE | Research Site | Edegem,
BE,
2650 | | Withdrawn |
BE | Research Site | Leuven,
BE,
3000 | | Completed |
CA | Research Site | Toronto,
CA,
M5G 2M9 | | Completed |
DE | Research Site | Berlin,
DE,
10967 | | Completed |
DE | Research Site | Berlin,
DE,
D-13353 | | Completed |
DE | Research Site | Bochum,
DE,
44791 | | Active, not recruiting |
DE | Research Site | Bonn,
DE,
53127 | | Completed |
DE | Research Site | Dresden,
DE,
01307 | | Completed |
DE | Research Site | Frankfurt am Main,
DE,
60596 | | Completed |
DE | Research Site | Freiburg im Breisgau,
DE,
79106 | | Withdrawn |
DE | Research Site | Hamburg,
DE,
22291 | | Completed |
DE | Research Site | Hamburg,
DE,
20246 | | Completed |
DE | Research Site | Hannover,
DE,
30625 | | Completed |
DE | Research Site | Leipzig,
DE,
04103 | | Completed |
DE | Research Site | München,
DE,
81675 | | Active, not recruiting |
DE | Research Site | Schweinfurt,
DE,
97422 | | Completed |
DE | Research Site | Ulm,
DE,
89081 | | Completed |
AU | Research Site | Campbelltown,
AU,
2560 | | Completed |
AU | Research Site | Lilydale,
AU,
3140 | | Withdrawn |
AU | Research Site | Randwick,
AU,
2031 | | Completed |
AU | Research Site | St Leonards,
AU,
2065 | | Completed |
AU | Research Site | Woolloongabba,
AU,
4102 | | Withdrawn |
CA
, ON | Research Site | London,
ON,
CA,
N6A 4L6 | | Completed |
CA
, ON | Research Site | Ottawa,
ON,
CA,
K1H 8L6 | | Withdrawn |
IL | Research Site | Beer Sheva,
IL,
84101 | | Completed |
IL | Research Site | Haifa,
IL,
3109601 | | Completed |
IL | Research Site | Holon,
IL,
58100 | | Completed |
IL | Research Site | Nahariya,
IL,
22100 | | Completed |
IL | Research Site | Petah Tikva,
IL,
4941492 | | Active, not recruiting |
IL | Research Site | Ramat Gan,
IL,
5265601 | | Active, not recruiting |
IL | Research Site | Rehovot,
IL,
76100 | | Completed |
IL | Research Site | Tel Aviv,
IL,
6423906 | | Completed |
IL | Research Site | Zefir,
IL,
7030000 | | Completed |
ES | Research Site | Barcelona,
ES,
08035 | | Completed |
ES | Research Site | Girona,
ES,
17007 | | Completed |
ES | Research Site | L'Hospitalet de Llobregat,
ES,
08907 | | Completed |
ES | Research Site | Madrid,
ES,
28007 | | Completed |
ES | Research Site | Madrid,
ES,
28034 | | Completed |
ES | Research Site | Madrid,
ES,
28050 | | Completed |
ES | Research Site | Madrid,
ES,
28041 | | Completed |
ES | Research Site | Málaga,
ES,
29010 | | Completed |
ES | Research Site | Pamplona,
ES,
31008 | | Completed |
ES | Research Site | Sabadell,
ES,
8208 | | Completed |
ES | Research Site | Santiago de Compostela,
ES,
15706 | | Completed |
ES | Research Site | Valencia,
ES,
46009 | | Completed |
ES | Research Site | Zaragoza,
ES,
50009 | | Completed |
GB | Research Site | Edinburgh,
GB,
EH4 2XR | | Completed |
GB | Research Site | Glasgow,
GB,
G12 0YN | | Completed |
GB | Research Site | Leeds,
GB,
LS9 7TF | | Withdrawn |
GB | Research Site | Liverpool,
GB,
L69 3GA | | Completed |
GB | Research Site | London,
GB,
WC1E 6AG | | Completed |
GB | Research Site | London,
GB,
SE5 9RS | | Completed |
GB | Research Site | Manchester,
GB,
M20 4BX | | Completed |
GB | Research Site | Northwood,
GB,
HA6 2RN | | Completed |
GB | Research Site | Nottingham,
GB,
NG5 1PB | | Completed |
GB | Research Site | Surrey,
GB,
SM1 2DL | | Completed |
FR | Research Site | Amiens,
FR,
80054 | | Completed |
FR | Research Site | Besançon,
FR,
25000 | | Completed |
FR | Research Site | Bordeaux,
FR,
33075 | | Completed |
FR | Research Site | Brest Cedex,
FR,
29609 | | Completed |
FR | Research Site | Clichy Cedex,
FR,
92118 | | Active, not recruiting |
FR | Research Site | La Roche sur Yon,
FR,
85925 | | Completed |
FR | Research Site | LILLE,
FR,
59020 | | Active, not recruiting |
FR | Research Site | Lyon,
FR,
69008 | | Withdrawn |
FR | Research Site | LYON CEDEX 03,
FR,
69437 | | Completed |
FR | Research Site | Montpellier,
FR,
34298 | | Withdrawn |
FR | Research Site | Nice,
FR,
06189 | | Completed |
FR | Research Site | PARIS,
FR,
75014 | | Completed |
FR | Research Site | Paris CEDEX 14,
FR,
75674 | | Completed |
FR | Research Site | POITIERS,
FR,
86021 | | Completed |
FR | Research Site | Rennes,
FR,
35042 | | Withdrawn |
FR | Research Site | STRASBOURG Cedex,
FR,
67065 | | Completed |
FR | Research Site | Toulouse,
FR,
31059 | | Completed |
FR | Research Site | Villejuif,
FR,
94800 | | Completed |
KR | Research Site | Seongnam-si,
KR,
13620 | | Completed |
KR | Research Site | Seoul,
KR,
03080 | | Active, not recruiting |
KR | Research Site | Seoul,
KR,
6351 | | Active, not recruiting |
US
, CA | Research Site | Downey,
CA,
US,
90241 | | Withdrawn |
US
, CA | Research Site | La Jolla,
CA,
US,
92093 | | Withdrawn |
US
, CA | Research Site | Los Angeles,
CA,
US,
90025 | | Withdrawn |
US
, CA | Research Site | Los Angeles,
CA,
US,
90089 | | Withdrawn |
US
, CA | Research Site | Orange,
CA,
US,
92868 | | Completed |
US
, CA | Research Site | Santa Monica,
CA,
US,
90404 | | Withdrawn |
US
, CA | Research Site | Stanford,
CA,
US,
94305-5720 | | Completed |
IT | Research Site | Ancona,
IT,
60126 | | Withdrawn |
IT | Research Site | Bologna,
IT,
40138 | | Completed |
IT | Research Site | Milano,
IT,
20132 | | Completed |
IT | Research Site | Milano,
IT,
20133 | | Completed |
IT | Research Site | Monserrato,
IT,
09042 | | Withdrawn |
IT | Research Site | Padova,
IT,
35128 | | Completed |
IT | Research Site | Parma,
IT,
43126 | | Completed |
IT | Research Site | Pescara,
IT,
65100 | | Completed |
IT | Research Site | Pisa,
IT,
56126 | | Withdrawn |
IT | Research Site | Roma,
IT,
00144 | | Completed |
IT | Research Site | Roma,
IT,
00128 | | Completed |
IT | Research Site | San Giovanni Rotondo,
IT,
71013 | | Completed |
IT | Research Site | Verona,
IT,
37134 | | Active, not recruiting |
US
, IL | Research Site | Chicago,
IL,
US,
60637 | | Completed |
US
, IL | Research Site | Evanston,
IL,
US,
60201 | | Withdrawn |
US
, MD | Research Site | Baltimore,
MD,
US,
21287 | | Completed |
US
, MD | Research Site | Bethesda,
MD,
US,
20889 | | Withdrawn |
US
, PA | Research Site | Philadelphia,
PA,
US,
19111 | | Completed |
US
, CT | Research Site | New Haven,
CT,
US,
06510 | | Completed |
US
, OH | Research Site | Columbus,
OH,
US,
43210 | | Completed |
US
, CO | Research Site | Aurora,
CO,
US,
80045 | | Completed |
US
, FL | Research Site | Boca Raton,
FL,
US,
33486 | | Active, not recruiting |
US
, FL | Research Site | Miami,
FL,
US,
33136 | | Completed |
US
, FL | Research Site | Miami,
FL,
US,
33136 | | Withdrawn |
US
, NY | Research Site | Commack,
NY,
US,
11725 | | Completed |
US
, NY | Research Site | New York,
NY,
US,
10032 | | Completed |
US
, NY | Research Site | New York,
NY,
US,
10022 | | Completed |
US
, NY | Research Site | New York,
NY,
US,
10065 | | Completed |
US
, NY | Research Site | New York,
NY,
US,
10016 | | Completed |
US
, NY | Research Site | Sleepy Hollow,
NY,
US,
10591 | | Withdrawn |
US
, NY | Research Site | West Harrison,
NY,
US,
10604 | | Withdrawn |
US
, MO | Research Site | Saint Louis,
MO,
US,
63110 | | Completed |
CA
, Quebec | Research Site | Montreal,
Quebec,
CA,
H3T 1E2 | | Completed |
US
, AZ | Research Site | Gilbert,
AZ,
US,
85234 | | Completed |
NL | Research Site | Amsterdam,
NL,
1105 AZ | | Completed |
NL | Research Site | Maastricht,
NL,
6202 AZ | | Withdrawn |
CA
, QC | Research Site | Montreal,
QC,
CA,
H2X 3J4 | | Withdrawn |
CA
, QC | Research Site | Sherbrooke,
QC,
CA,
J1G 2E8 | | Completed |
US
, WA | Research Site | Seattle,
WA,
US,
98104 | | Completed |
US
, WA | Research Site | Seattle,
WA,
US,
98109 | | Withdrawn |
US
, TX | Research Site | Arlington,
TX,
US,
76012 | | Withdrawn |
US
, TX | Research Site | Dallas,
TX,
US,
75390 | | Withdrawn |
US
, TX | Research Site | Houston,
TX,
US,
77030 | | Completed |
US
, MA | Research Site | Boston,
MA,
US,
02215 | | Completed |
US
, MA | Research Site | Boston,
MA,
US,
02114 | | Withdrawn |
CA
, MB | Research Site | Winnipeg,
MB,
CA,
R2H 2A6 | | Withdrawn |
US
, NJ | Research Site | Basking Ridge,
NJ,
US,
07920 | | Withdrawn |
US
, New York | Research Site | Rockville Centre,
New York,
US,
11570-1000 | | Withdrawn |
US
, DC | Research Site | Washington,
DC,
US,
20007 | | Withdrawn |
US
, SC | Research Site | Spartanburg,
SC,
US,
29303 | | Withdrawn |
US
, GA | Research Site | Atlanta,
GA,
US,
30318 | | Withdrawn |
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations
|
---|
This study randomised patients at a total of 59 study centres in 12 countries: United States of America (13), Germany (8), France (7), Israel (7), Spain (7), United Kingdom (6), Italy (4), Belgium (2), Republic of Korea (2), Australia (1), Canada (1) and Netherlands (1). |
Pre-Assignment Details
Significant events and approaches for the overall
study following participant enrollment, but prior to group assignment
|
---|
Screening Part 1 was only required if a patient’s gBRCAm status was unknown and Screening Part 2 was for patients with known local germline BRCA (gBRCA) test. All other screening parameters were done as per the Study Schedule. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Participant Flow: Overall Study
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
STARTED | 92 | 62 |
---|
COMPLETED | 49 | 27 |
---|
NOT COMPLETED | 43 | 35 |
---|
Patient decision
| 3 | 1 |
---|
Eligibility criteria not fulfilled
| 0 | 1 |
---|
Death
| 40 | 29 |
---|
Lost to Follow-up
| 0 | 2 |
---|
Other
| 0 | 2 |
---|
Baseline Characteristics
Analysis Population Description --
Explanation of how the number of participants for analysis was determined. Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Baseline Measures
| Olaparib 300 mg twice daily (bd) | Placebo | Total |
---|
Number of Participants
[units: Participants]
| 92 | 62 | 154 |
---|
Age Continuous
[units: Years]
Mean ± Standard Deviation |
---|
Sex: Female, Male
[units: Participants]
|
---|
|
|
Race (NIH/OMB)
[units: Participants]
|
---|
|
|
|
|
|
|
|
Ethnicity (NIH/OMB)
[units: Participants]
|
---|
|
|
|
Outcome Measures
1. Primary Outcome Measure: Progression-free survival (PFS) by blinded independent central review (BICR) using modified Response Evaluation Criteria in Solid Tumours. This study used modified RECIST version (v) 1.1 (RECIST v1.1) [ Time Frame: Up to 4 years ]
Measure Type | Primary |
---|
Measure Name | Progression-free survival (PFS) by blinded independent central review (BICR) using modified Response Evaluation Criteria in Solid Tumours. This study used modified RECIST version (v) 1.1 (RECIST v1.1) |
---|
Measure Description | To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression. |
---|
Time Frame | Up to 4 years |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation
(gBRCAm) subgroup. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 92 | 62 |
---|
Progression-free survival (PFS) by blinded independent central review (BICR) using modified Response Evaluation Criteria in Solid Tumours. This study used modified RECIST version (v) 1.1 (RECIST v1.1)
[units: Months] Median (95% Confidence Interval)
| 7.4
(4.14 to 11.01)
| 3.8
(3.52 to 4.86)
|
---|
Statistical Analysis 1 for Progression-free survival (PFS) by blinded independent central review (BICR) using modified Response Evaluation Criteria in Solid Tumours. This study used modified RECIST version (v) 1.1 (RECIST v1.1)
Groups
[1]
|
All groups
|
---|
Method
[3]
| Other [Log-rank test] |
---|
P-Value
[4]
| 0.0038 |
---|
Hazard Ratio (HR)
[5]
| 0.531 |
---|
95% Confidence Interval | ( 0.346 to 0.815 ) |
---|
2. Secondary Outcome Measure: Overall Survival (OS) [ Time Frame: Upto 4 years ]
Measure Type | Secondary |
---|
Measure Name | Overall Survival (OS) |
---|
Measure Description | To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause. |
---|
Time Frame | Upto 4 years |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation
(gBRCAm) subgroup. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 92 | 62 |
---|
Overall Survival (OS)
[units: Months] Median (95% Confidence Interval)
| 18.9
(14.85 to 26.15)
| 18.1
(12.62 to 26.12)
|
---|
Statistical Analysis 1 for Overall Survival (OS)
Groups
[1]
|
All groups
|
---|
Method
[3]
| Other [Log-rank test] |
---|
P-Value
[4]
| 0.6833 |
---|
Hazard Ratio (HR)
[5]
| 0.906 |
---|
95% Confidence Interval | ( 0.563 to 1.457 ) |
---|
3. Secondary Outcome Measure: Time from randomisation to second progression (PFS2) [ Time Frame: Up to 4 years ]
Measure Type | Secondary |
---|
Measure Name | Time from randomisation to second progression (PFS2) |
---|
Measure Description | To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the
progression event subsequent to that used for the primary variable PFS or death. |
---|
Time Frame | Up to 4 years |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation
(gBRCAm) subgroup. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 92 | 62 |
---|
Time from randomisation to second progression (PFS2)
[units: Months] Median (95% Confidence Interval)
| 13.2
(7.75 to 26.15)
| 9.2
(7.62 to 13.54)
|
---|
Statistical Analysis 1 for Time from randomisation to second progression (PFS2)
Groups
[1]
|
All groups
|
---|
Method
[3]
| Other [Log-rank test] |
---|
P-Value
[4]
| 0.2597 |
---|
Hazard Ratio (HR)
[5]
| 0.755 |
---|
95% Confidence Interval | ( 0.464 to 1.230 ) |
---|
4. Secondary Outcome Measure: Time from randomisation to second subsequent therapy or death (TSST) [ Time Frame: Up to 4 years ]
Measure Type | Secondary |
---|
Measure Name | Time from randomisation to second subsequent therapy or death (TSST) |
---|
Measure Description | To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death. |
---|
Time Frame | Up to 4 years |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation
(gBRCAm) subgroup. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 92 | 62 |
---|
Time from randomisation to second subsequent therapy or death (TSST)
[units: Months] Median (95% Confidence Interval)
| 13.2
(8.84 to 20.04)
| 9.2
(8.34 to 13.14)
|
---|
Statistical Analysis 1 for Time from randomisation to second subsequent therapy or death (TSST)
Groups
[1]
|
All groups
|
---|
Method
[3]
| Other [Log-rank test] |
---|
P-Value
[4]
| 0.0825 |
---|
Hazard Ratio (HR)
[5]
| 0.678 |
---|
95% Confidence Interval | ( 0.437 to 1.051 ) |
---|
5. Secondary Outcome Measure: Time from randomisation to first subsequent therapy or death (TFST) [ Time Frame: Up to 4 years ]
Measure Type | Secondary |
---|
Measure Name | Time from randomisation to first subsequent therapy or death (TFST) |
---|
Measure Description | To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death. |
---|
Time Frame | Up to 4 years |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation
(gBRCAm) subgroup. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 92 | 62 |
---|
Time from randomisation to first subsequent therapy or death (TFST)
[units: Months] Median (95% Confidence Interval)
| 8.6
(6.21 to 12.45)
| 5.7
(4.17 to 6.34)
|
---|
Statistical Analysis 1 for Time from randomisation to first subsequent therapy or death (TFST)
Groups
[1]
|
All groups
|
---|
Method
[3]
| Other [Log-rank test] |
---|
P-Value
[4]
| 0.0013 |
---|
Hazard Ratio (HR)
[5]
| 0.496 |
---|
95% Confidence Interval | ( 0.324 to 0.760 ) |
---|
6. Secondary Outcome Measure: Time from randomisation to study treatment discontinuation or death (TDT) [ Time Frame: Up to 4 years ]
Measure Type | Secondary |
---|
Measure Name | Time from randomisation to study treatment discontinuation or death (TDT) |
---|
Measure Description | To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death. |
---|
Time Frame | Up to 4 years |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation
(gBRCAm) subgroup. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 92 | 62 |
---|
Time from randomisation to study treatment discontinuation or death (TDT)
[units: Months] Median (95% Confidence Interval)
| 7.2
(5.52 to 10.84)
| 3.8
(3.55 to 4.80)
|
---|
Statistical Analysis 1 for Time from randomisation to study treatment discontinuation or death (TDT)
Groups
[1]
|
All groups
|
---|
Method
[3]
| Other [Log-rank test] |
---|
P-Value
[4]
| 0.0001 |
---|
Hazard Ratio (HR)
[5]
| 0.446 |
---|
95% Confidence Interval | ( 0.297 to 0.670 ) |
---|
7. Secondary Outcome Measure: Number of participants with objective response rate (ORR) by BICR using modified RECIST 1.1 [ Time Frame: Up to 4 years ]
Measure Type | Secondary |
---|
Measure Name | Number of participants with objective response rate (ORR) by BICR using modified RECIST 1.1 |
---|
Measure Description | To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared
to placebo. The ORR is defined as the number of with a BoR of CR and
PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline. |
---|
Time Frame | Up to 4 years |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
All randomised patients with measurable disease at baseline. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 78 | 52 |
---|
Number of participants with objective response rate (ORR) by BICR using modified RECIST 1.1
[units: Participants]
| 18 | 6 |
---|
Statistical Analysis 1 for Number of participants with objective response rate (ORR) by BICR using modified RECIST 1.1
Groups
[1]
|
All groups
|
---|
Method
[3]
| Regression, Logistic |
---|
P-Value
[4]
| 0.1028 |
---|
Odds Ratio (OR)
[5]
| 2.300 |
---|
95% Confidence Interval | ( 0.886 to 6.761 ) |
---|
8. Secondary Outcome Measure: Disease control rate (DCR) by BICR using modified RECIST 1.1 [ Time Frame: At 16 weeks ]
Measure Type | Secondary |
---|
Measure Name | Disease control rate (DCR) by BICR using modified RECIST 1.1 |
---|
Measure Description | Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to
placebo. |
---|
Time Frame | At 16 weeks |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Intention to treat (ITT): All randomised patients |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 92 | 62 |
---|
Disease control rate (DCR) by BICR using modified RECIST 1.1
[units: Participants]
| | |
---|
Yes | 49 | 23 |
No | 41 | 35 |
Not evaluable/missing | 2 | 4 |
9. Secondary Outcome Measure: Adjusted mean change from baseline up to 6 months in global quality of life (QoL) score from the EORTC-QLQ-C30 questionnaire [ Time Frame: From baseline up to 6 months ]
Measure Type | Secondary |
---|
Measure Name | Adjusted mean change from baseline up to 6 months in global quality of life (QoL) score from the EORTC-QLQ-C30 questionnaire |
---|
Measure Description | To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.
A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.
bd twice daily. |
---|
Time Frame | From baseline up to 6 months |
---|
Safety Issue? | No |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms. |
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 89 | 58 |
---|
Adjusted mean change from baseline up to 6 months in global quality of life (QoL) score from the EORTC-QLQ-C30 questionnaire
[units: Unit on scale] Mean (95% Confidence Interval)
| -1.20
(-4.014 to 1.618)
| 1.27
(-2.580 to 5.124)
|
---|
Statistical Analysis 1 for Adjusted mean change from baseline up to 6 months in global quality of life (QoL) score from the EORTC-QLQ-C30 questionnaire
Groups
[1]
|
All groups
|
---|
Method
[3]
| Mixed Models Analysis |
---|
P-Value
[4]
| 0.310 |
---|
Mean Difference (Final Values)
[5]
| -2.47 |
---|
95% Confidence Interval | ( -7.267 to 2.327 ) |
---|
10. Secondary Outcome Measure: Number of participants with adverse events (AEs) [ Time Frame: Up to 4 years ]
Measure Type | Secondary |
---|
Measure Name | Number of participants with adverse events (AEs) |
---|
Measure Description | To assess the safety and tolerability
of olaparib maintenance
monotherapy.
SAE: serious adverse events
CTCAE: Common Terminology Criteria for Adverse Events |
---|
Time Frame | Up to 4 years |
---|
Safety Issue? | Yes |
---|
Population Description
Explanation of how the number of
participants for analysis was determined. Includes whether analysis was per protocol,
intention to treat, or another method. Also provides relevant details such as imputation
technique, as appropriate.
|
---|
|
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Measured Values
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Number of
Participants Analyzed
[units:participants]
| 91 | 60 |
---|
Number of participants with adverse events (AEs)
[units: Participants]
| | |
---|
Any AE | 87 | 56 |
Any AE of CTCAE Grade 3 or higher | 36 | 14 |
Any AE with outcome = death | 0 | 0 |
Any SAE (including events with outcome = death) | 22 | 9 |
AnyAE leading to withdrawal of olaparib/placebo | 5 | 1 |
Any AE leading to dose interruption | 32 | 3 |
Any AE leading to dose reduction | 15 | 2 |
Serious Adverse Events
Time Frame | From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). |
---|
Additional Description | No text entered. |
---|
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Serious Adverse Events
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Total,
serious adverse events
| | |
---|
# participants
affected / at risk
| 22/91 (24.18%) | 9/60 (15.00%) |
Infections and infestations | | |
---|
Abdominal infection1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Infections and infestations | | |
---|
Bartholinitis1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Infections and infestations | | |
---|
Pneumonia1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Infections and infestations | | |
---|
Urinary tract infection1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Blood and lymphatic system disorders | | |
---|
Anaemia1 | | |
# participants affected / at risk | 6/91 (6.59%) | 0/60 (0.00%) |
|
Blood and lymphatic system disorders | | |
---|
Febrile Neutropenia1 | | |
# participants affected / at risk | 0/91 (0.00%) | 1/60 (1.67%) |
|
Endocrine disorders | | |
---|
Hypothyroidism1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Metabolism and nutrition disorders | | |
---|
Decreased appetite1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Metabolism and nutrition disorders | | |
---|
Hyperglycaemia1 | | |
# participants affected / at risk | 0/91 (0.00%) | 1/60 (1.67%) |
|
Nervous system disorders | | |
---|
Cerebrovascular accident1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Nervous system disorders | | |
---|
Embolic stroke1 | | |
# participants affected / at risk | 0/91 (0.00%) | 1/60 (1.67%) |
|
Nervous system disorders | | |
---|
Transient ischaemic attack1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Cardiac disorders | | |
---|
Cardiac failure1 | | |
# participants affected / at risk | 1/91 (1.10%) | 1/60 (1.67%) |
|
Vascular disorders | | |
---|
Vascular stenosis1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Respiratory, thoracic and mediastinal disorders | | |
---|
Pleural effusion1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Respiratory, thoracic and mediastinal disorders | | |
---|
Pneumothorax1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Abdominal pain1 | | |
# participants affected / at risk | 3/91 (3.30%) | 1/60 (1.67%) |
|
Gastrointestinal disorders | | |
---|
Constipation1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Duodenal perforation1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Gastric varices haemorrhage1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Incarcerated inguinal hernia1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Large intestinal obstruction1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Melaena1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Obstruction gastric1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Pancreatitis1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Gastrointestinal disorders | | |
---|
Vomiting1 | | |
# participants affected / at risk | 1/91 (1.10%) | 3/60 (5.00%) |
|
Hepatobiliary disorders | | |
---|
Bile duct obstruction1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Hepatobiliary disorders | | |
---|
Cholangitis1 | | |
# participants affected / at risk | 2/91 (2.20%) | 1/60 (1.67%) |
|
Hepatobiliary disorders | | |
---|
Cholecystitis1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
General disorders | | |
---|
General physical health deterioration1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Investigations | | |
---|
Platelet count decreased1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Injury, poisoning and procedural complications | | |
---|
Anastomotic haemorrhage1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Product Issues | | |
---|
Device occlusion1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
Product Issues | | |
---|
Stent malfunction1 | | |
# participants affected / at risk | 1/91 (1.10%) | 0/60 (0.00%) |
|
General disorders | | |
---|
Pyrexia1 | | |
# participants affected / at risk | 0/91 (0.00%) | 2/60 (3.33%) |
|
|
Other Adverse Events
Time Frame | From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). |
---|
Additional Description | No text entered. |
---|
Frequency Threshold
Threshold above which other adverse events are reported
| 5%
|
---|
Reporting Groups
| Description |
---|
Olaparib 300 mg twice daily (bd) | Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Placebo | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
---|
Other Adverse Events
| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Total, other (not including serious) adverse events
| | |
---|
# participants affected / at risk
| 87/91 (95.60%) | 56/60 (93.33%) |
Gastrointestinal disorders | | |
---|
Nausea1 | | |
# participants affected / at risk | 41/91 (45.05%) | 14/60 (23.33%) |
|
Gastrointestinal disorders | | |
---|
Diarrhoea1 | | |
# participants affected / at risk | 26/91 (28.57%) | 9/60 (15.00%) |
|
Gastrointestinal disorders | | |
---|
Abdominal pain1 | | |
# participants affected / at risk | 23/91 (25.27%) | 14/60 (23.33%) |
|
Gastrointestinal disorders | | |
---|
Constipation1 | | |
# participants affected / at risk | 20/91 (21.98%) | 6/60 (10.00%) |
|
Gastrointestinal disorders | | |
---|
Vomiting1 | | |
# participants affected / at risk | 18/91 (19.78%) | 8/60 (13.33%) |
|
Gastrointestinal disorders | | |
---|
Stomatitis1 | | |
# participants affected / at risk | 7/91 (7.69%) | 3/60 (5.00%) |
|
Gastrointestinal disorders | | |
---|
Abdominal pain upper1 | | |
# participants affected / at risk | 6/91 (6.59%) | 8/60 (13.33%) |
|
Gastrointestinal disorders | | |
---|
Dry mouth1 | | |
# participants affected / at risk | 6/91 (6.59%) | 1/60 (1.67%) |
|
Gastrointestinal disorders | | |
---|
Dyspepsia1 | | |
# participants affected / at risk | 5/91 (5.49%) | 5/60 (8.33%) |
|
Gastrointestinal disorders | | |
---|
Abdominal distension1 | | |
# participants affected / at risk | 4/91 (4.40%) | 6/60 (10.00%) |
|
Gastrointestinal disorders | | |
---|
Flatulence1 | | |
# participants affected / at risk | 2/91 (2.20%) | 4/60 (6.67%) |
|
General disorders | | |
---|
Fatigue1 | | |
# participants affected / at risk | 41/91 (45.05%) | 16/60 (26.67%) |
|
General disorders | | |
---|
Asthenia1 | | |
# participants affected / at risk | 15/91 (16.48%) | 5/60 (8.33%) |
|
General disorders | | |
---|
Pyrexia1 | | |
# participants affected / at risk | 12/91 (13.19%) | 3/60 (5.00%) |
|
General disorders | | |
---|
Oedema peripheral1 | | |
# participants affected / at risk | 8/91 (8.79%) | 5/60 (8.33%) |
|
Musculoskeletal and connective tissue disorders | | |
---|
Back pain1 | | |
# participants affected / at risk | 17/91 (18.68%) | 10/60 (16.67%) |
|
Musculoskeletal and connective tissue disorders | | |
---|
Arthralgia1 | | |
# participants affected / at risk | 14/91 (15.38%) | 6/60 (10.00%) |
|
Musculoskeletal and connective tissue disorders | | |
---|
Muscle spasms1 | | |
# participants affected / at risk | 6/91 (6.59%) | 2/60 (3.33%) |
|
Musculoskeletal and connective tissue disorders | | |
---|
Pain in extremity1 | | |
# participants affected / at risk | 6/91 (6.59%) | 4/60 (6.67%) |
|
Musculoskeletal and connective tissue disorders | | |
---|
Musculoskeletal pain1 | | |
# participants affected / at risk | 5/91 (5.49%) | 3/60 (5.00%) |
|
Musculoskeletal and connective tissue disorders | | |
---|
Myalgia1 | | |
# participants affected / at risk | 5/91 (5.49%) | 3/60 (5.00%) |
|
Musculoskeletal and connective tissue disorders | | |
---|
Flank pain1 | | |
# participants affected / at risk | 1/91 (1.10%) | 4/60 (6.67%) |
|
Nervous system disorders | | |
---|
Dysgeusia1 | | |
# participants affected / at risk | 10/91 (10.99%) | 3/60 (5.00%) |
|
Nervous system disorders | | |
---|
Neuropathy peripheral1 | | |
# participants affected / at risk | 7/91 (7.69%) | 7/60 (11.67%) |
|
Nervous system disorders | | |
---|
Dizziness1 | | |
# participants affected / at risk | 6/91 (6.59%) | 3/60 (5.00%) |
|
Nervous system disorders | | |
---|
Headache1 | | |
# participants affected / at risk | 6/91 (6.59%) | 8/60 (13.33%) |
|
Nervous system disorders | | |
---|
Peripheral sensory neuropathy1 | | |
# participants affected / at risk | 6/91 (6.59%) | 2/60 (3.33%) |
|
Blood and lymphatic system disorders | | |
---|
Anaemia1 | | |
# participants affected / at risk | 23/91 (25.27%) | 10/60 (16.67%) |
|
Blood and lymphatic system disorders | | |
---|
Neutropenia1 | | |
# participants affected / at risk | 7/91 (7.69%) | 4/60 (6.67%) |
|
Blood and lymphatic system disorders | | |
---|
Thrombocytopenia1 | | |
# participants affected / at risk | 7/91 (7.69%) | 4/60 (6.67%) |
|
Metabolism and nutrition disorders | | |
---|
Decreased appetite1 | | |
# participants affected / at risk | 22/91 (24.18%) | 4/60 (6.67%) |
|
Metabolism and nutrition disorders | | |
---|
Hyperglycaemia1 | | |
# participants affected / at risk | 8/91 (8.79%) | 1/60 (1.67%) |
|
Skin and subcutaneous tissue disorders | | |
---|
Rash1 | | |
# participants affected / at risk | 11/91 (12.09%) | 2/60 (3.33%) |
|
Skin and subcutaneous tissue disorders | | |
---|
Pruritus1 | | |
# participants affected / at risk | 9/91 (9.89%) | 4/60 (6.67%) |
|
Investigations | | |
---|
Alanine aminotransferase increased1 | | |
# participants affected / at risk | 8/91 (8.79%) | 1/60 (1.67%) |
|
Investigations | | |
---|
Aspartate aminotransferase increased1 | | |
# participants affected / at risk | 6/91 (6.59%) | 1/60 (1.67%) |
|
Investigations | | |
---|
Blood creatinine increased1 | | |
# participants affected / at risk | 6/91 (6.59%) | 1/60 (1.67%) |
|
Investigations | | |
---|
Blood alkaline phosphatase increased1 | | |
# participants affected / at risk | 5/91 (5.49%) | 3/60 (5.00%) |
|
Investigations | | |
---|
Platelet count decreased1 | | |
# participants affected / at risk | 5/91 (5.49%) | 0/60 (0.00%) |
|
Psychiatric disorders | | |
---|
Insomnia1 | | |
# participants affected / at risk | 7/91 (7.69%) | 1/60 (1.67%) |
|
Psychiatric disorders | | |
---|
Anxiety1 | | |
# participants affected / at risk | 5/91 (5.49%) | 2/60 (3.33%) |
|
Psychiatric disorders | | |
---|
Depression1 | | |
# participants affected / at risk | 5/91 (5.49%) | 0/60 (0.00%) |
|
Respiratory, thoracic and mediastinal disorders | | |
---|
Dyspnoea1 | | |
# participants affected / at risk | 10/91 (10.99%) | 3/60 (5.00%) |
|
Respiratory, thoracic and mediastinal disorders | | |
---|
Cough1 | | |
# participants affected / at risk | 8/91 (8.79%) | 2/60 (3.33%) |
|
Infections and infestations | | |
---|
Nasopharyngitis1 | | |
# participants affected / at risk | 11/91 (12.09%) | 2/60 (3.33%) |
|
Infections and infestations | | |
---|
Influenza1 | | |
# participants affected / at risk | 5/91 (5.49%) | 0/60 (0.00%) |
|
|
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
|
There IS 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.
|
The agreement is:
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is
more than 60 days but less than
or equal to 180 days
. The sponsor cannot require changes to the communication and cannot extend the embargo.
|
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
This submission /document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object. |
|
Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data
|
---|
No text entered.
|
Results Point of Contact
Name/Title: | Global Clinical Leader |
Organization: | AstraZeneca AB |
Phone | 1-877-240-9479
|
E-mail: | [email protected] |
.