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A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer. (OReO)

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ClinicalTrials.gov Identifier: NCT03106987
Recruitment Status : Completed
First Posted : April 11, 2017
Results First Posted : April 19, 2022
Last Update Posted : October 7, 2022
Sponsor:
Collaborator:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Epithelial Ovarian Cancer
Interventions Drug: Active Comparator: Olaparib tablets
Drug: Placebo
Enrollment 220
Recruitment Details This study was conducted at study centres in 11 countries (France, Italy, Spain, Germany, Poland, Belgium, Denmark, Israel, United Kingdom, Norway, and Canada) between 8-Jun-2017 and 15-Feb-2021.
Pre-assignment Details Patients were randomised into 1 of 2 cohorts depending on their known BRCA1/2 status (BRCA1/2 +ve or BRCA1/2-ve). Within each cohort, patients were randomised in a 2 Olaparib:1 placebo ratio. Randomisation was stratified by prior use of bevacizumab and number of prior regimens of platinum-containing chemotherapy.
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description Patients received olaparib 300mg tablets orally twice daily (bd) continuously Patients received placebo 300mg tablets administered orally twice daily (bd) continuously Patients received olaparib 300mg tablets orally twice daily (bd) continuously Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Period Title: Overall Study
Started 74 38 72 36
Completed 30 15 54 25
Not Completed 44 23 18 11
Reason Not Completed
Death             37             22             12             8
Lost to Follow-up             2             0             2             2
Withdrawal by Subject             5             1             4             1
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA 1/2 -ve) Total
Hide Arm/Group Description Patients received olaparib 300mg tablets orally twice daily (bd) continuously Patients received placebo 300mg tablets administered orally twice daily (bd) continuously Patients received olaparib 300mg tablets orally twice daily (bd) continuously Patients received placebo 300mg tablets administered orally twice daily (bd) continuously Total of all reporting groups
Overall Number of Baseline Participants 74 38 72 36 220
Hide Baseline Analysis Population Description
Full analysis set (FAS) consisted of all randomised patients analysed on an intent-to-treat (ITT) basis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 38 participants 72 participants 36 participants 220 participants
59.2  (9.31) 61.5  (9.22) 64.2  (9.64) 63.3  (9.05) 61.9  (9.54)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 38 participants 72 participants 36 participants 220 participants
< 50
11
  14.9%
3
   7.9%
4
   5.6%
1
   2.8%
19
   8.6%
≥ 50 to < 65
40
  54.1%
20
  52.6%
29
  40.3%
19
  52.8%
108
  49.1%
≥ 65 to < 75
20
  27.0%
12
  31.6%
30
  41.7%
11
  30.6%
73
  33.2%
≥ 75
3
   4.1%
3
   7.9%
9
  12.5%
5
  13.9%
20
   9.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 38 participants 72 participants 36 participants 220 participants
Female
74
 100.0%
38
 100.0%
72
 100.0%
36
 100.0%
220
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 38 participants 72 participants 36 participants 220 participants
White
71
  95.9%
35
  92.1%
66
  91.7%
33
  91.7%
205
  93.2%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.5%
Hawaiian Native or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
3
   4.1%
3
   7.9%
5
   6.9%
2
   5.6%
13
   5.9%
Missing Data
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.8%
1
   0.5%
1.Primary Outcome
Title Efficacy: Progression-free Survival (PFS)
Hide Description PFS (per RECIST 1.1) was defined as the time from randomisation until the date of Investigator assessed objective radiological disease progression or death (by any cause in the absence of disease progression). Objective progression (per RECIST 1.1) is defined as at least a 20% increase in the sum of the diameters of the target lesions and an absolute increase of >5 mm, or an overall non-target lesion assessment of progression or a new lesion. Patients who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
Time Frame At randomization visit and at every 12 weeks (+/- 7 days) until objective radiological disease progression as determined by the investigator or other discontinuation criteria are met (assessed upto 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) consisted of all randomised patients analysed on an intent-to-treat (ITT) basis
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
4.3
(2.79 to 5.49)
2.8
(2.73 to 4.96)
5.3
(2.89 to 5.55)
2.8
(2.79 to 2.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib (BRCA1/2 +ve), Placebo (BRCA1/2 +ve)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0220
Comments [Not Specified]
Method Stratified log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.566
Confidence Interval (2-Sided) 95%
0.372 to 0.868
Estimation Comments Hazard Ratio (Cox Proportional Hazards model)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olaparib (BRCA1/2 -ve), Placebo (BRCA1/2 -ve)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method Stratified log-rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.430
Confidence Interval (2-Sided) 95%
0.264 to 0.708
Estimation Comments Hazard Ratio (Cox Proportional Hazards model)
2.Secondary Outcome
Title Efficacy: Overall Survival (OS)
Hide Description OS was defined as the time from the date of randomisation until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive
Time Frame From randomisation till Long-term follow-up (12-weekly beyond 30 days after last dose of study treatment) assessed upto 3.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all randomised patients analysed on an ITT basis.
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
20.1
(16.39 to 25.43)
20.9
(15.21 to 23.92)
23.2 [1] 
(15.15 to NA)
30.2 [1] 
(17.84 to NA)
[1]
Upper limit was not calculated due to insufficient number of events.
3.Secondary Outcome
Title Efficacy: Time to Progression by Gynecologic Cancer Intergroup (GCIG) Criteria
Hide Description Time to progression by RECIST or CA-125 or death is defined as the time from randomisation to the earlier date of RECIST progression or CA-125 progression or death by any cause. Patients without a CA-125 progression or a RECIST progression who are still alive at the time of analysis will be censored at the time of their last evaluable RECIST assessment and/or their last available CA-125 measurement, whichever is the earliest at the time of analysis. Patients that do not have any evaluable RECIST assessments or any CA-125 results post-randomisation will be censored at the date of randomisation
Time Frame At screening (Visit 1) and at every 12 weeks (±7 days), until objective disease progression, based on progressive serial elevation of serum CA-125 according to the GCIG criteria, or until discontinuation for other reasons (assessed upto 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all randomised patients analysed on an ITT basis
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
2.8
(2.76 to 5.36)
2.8
(2.73 to 3.98)
2.9
(2.79 to 5.32)
2.79
(2.63 to 2.79)
4.Secondary Outcome
Title Efficacy: Time to First Subsequent Treatment Commencement (TFST)
Hide Description TFST was assessed as time from randomisation to first subsequent treatment commencement or death if this occurs before commencement of first subsequent treatment. Any patient not known to have had a further subsequent therapy or death was censored at the last known time to have not received subsequent therapy
Time Frame From follow-up i.e. 30 days after last dose of study medication till end of study (assessed every 12 weeks upto 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all randomised patients analysed on an ITT basis.
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
5.8
(4.67 to 9.17)
5.1
(3.58 to 6.11)
7.9
(5.88 to 11.07)
4.3
(3.68 to 6.41)
5.Secondary Outcome
Title Efficacy: Time to Second Subsequent Treatment Commencement (TSST)
Hide Description TSST was assessed as time from randomisation to second subsequent treatment commencement or death if this occurs before commencement of second subsequent treatment. Any patient not known to have had a further second subsequent therapy or death was censored at the last known time to have not received second subsequent therapy
Time Frame From follow-up i.e. 30 days after last dose of study medication till end of study (assessed every 12 weeks upto 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all randomised patients analysed on an ITT basis.
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
13.1
(11.10 to 15.64)
11.7
(8.61 to 13.60)
15.4
(11.60 to 23.62)
12.7
(10.35 to 16.62)
6.Secondary Outcome
Title Efficacy: Time to Study Treatment Discontinuation (TDT)
Hide Description TDT was assessed as time from randomisation to study treatment discontinuation or death if this occurs before discontinuation of study treatment. Any patient not known to have died at the time of analysis and not known to have discontinued study treatment was censored based on the last recorded date on which the patient was known to be alive
Time Frame From follow-up 30 days after last dose of study medication till long-term follow-up i.e. 12-weekly beyond 30 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all randomised patients analysed on an ITT basis.
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Median (95% Confidence Interval)
Unit of Measure: Months
4.5
(3.35 to 5.59)
3.4
(2.86 to 5.49)
5.6
(3.42 to 5.78)
3.1
(2.79 to 3.91)
7.Secondary Outcome
Title Efficacy: Change From Baseline in Health-related Quality of Life (HRQoL)
Hide Description Health related quality of life (HRQoL) of Olaparib maintenance retreatment compared to placebo as measured by the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) was determined. HRQoL was analysed using the FACT-O tool by mixed model for repeated measures (MMRM) analysis of the change from baseline in TOI score. FACT-O TOI is scored from O to 100 with higher scores denoting better quality of life. The higher the score, the better the HRQoL.
Time Frame At Baseline, and from Day 1 until objective disease progression (assessed upto 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Patient reported outcome (PRO) analysis set consisted of the FAS patients with a baseline PRO assessment
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 64 35 55 35
Mean (Standard Error)
Unit of Measure: Change in scores
-1.27  (0.55) 1.67  (0.89) -2.08  (0.60) 0.58  (0.90)
8.Secondary Outcome
Title Number of Patients With Adverse Events (AEs), and Serious Adverse Events (SAEs)
Hide Description All AEs/serious adverse events (SAEs) reported during the study were recorded.
Time Frame At Baseline and from Day 1 till follow-up i.e. 30 days after last dose of study medication (assessed upto 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all patients who received at least 1 dose of randomised study treatment, Olaparib or placebo
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Measure Type: Count of Participants
Unit of Measure: Participants
Any Treatment emergent adverse event (TEAE)
64
  86.5%
33
  86.8%
66
  91.7%
31
  86.1%
Any TEAE causally related to treatment
50
  67.6%
23
  60.5%
53
  73.6%
14
  38.9%
Any TEAE of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher
11
  14.9%
2
   5.3%
15
  20.8%
3
   8.3%
Any TEAE of CTCAE grade 3 or higher, causally related to treatment
5
   6.8%
1
   2.6%
5
   6.9%
1
   2.8%
Any TEAE with outcome = death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any TEAE with outcome = death, causally related to treatment
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any treatment-emergent SAE (including events with outcome = death)
5
   6.8%
0
   0.0%
11
  15.3%
2
   5.6%
Any treatment-emergent SAE (including events with outcome = death), causally related to treatment
1
   1.4%
0
   0.0%
3
   4.2%
0
   0.0%
Any TEAE leading to discontinuation of study medication
2
   2.7%
0
   0.0%
1
   1.4%
0
   0.0%
Any TEAE leading to discontinuation of study medication, causally related to treatment
1
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
Any TEAE leading to dose modification
18
  24.3%
6
  15.8%
28
  38.9%
2
   5.6%
Any TEAE leading to dose modification, causally related to treatment
14
  18.9%
5
  13.2%
21
  29.2%
1
   2.8%
9.Secondary Outcome
Title Number of Patients With Adverse Event of Special Interest (AESI).
Hide Description All AESIs reported during the study were recorded.
Time Frame At Baseline and from Day 1 till long-term follow-up i.e. 12-weekly beyond 30 days after last dose of study treatment (assessed upto 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all patients who received at least 1 dose of randomised study treatment, Olaparib or placebo
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description:
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Patients received olaparib 300mg tablets orally twice daily (bd) continuously
Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
Overall Number of Participants Analyzed 74 38 72 36
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
1
   2.6%
1
   1.4%
0
   0.0%
Time Frame From Screening (Day -27 to Day 0) up to 12-weekly beyond 30 days after the last dose of study treatment (assessed up to 3.8 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Hide Arm/Group Description Patients received olaparib 300mg tablets orally twice daily (bd) continuously Patients received placebo 300mg tablets administered orally twice daily (bd) continuously Patients received olaparib 300mg tablets orally twice daily (bd) continuously Patients received placebo 300mg tablets administered orally twice daily (bd) continuously
All-Cause Mortality
Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/74 (52.70%)   22/38 (57.89%)   15/72 (20.83%)   8/36 (22.22%) 
Hide Serious Adverse Events
Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/74 (6.76%)   0/38 (0.00%)   11/72 (15.28%)   2/36 (5.56%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Neutropenia * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Febrile neutropenia * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Cardiac disorders         
Supraventricular tachycardia * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Gastrointestinal disorders         
Diverticulum * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Ileal perforation * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Ileus * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Subileus * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
General disorders         
Pyrexia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
General physical health deterioration * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Incarcerated hernia * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Hepatobiliary disorders         
Hepatic haematoma * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Infections and infestations         
COVID-19 pneumonia * 1  2/74 (2.70%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Lower respiratory tract infection * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Sepsis * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Injury, poisoning and procedural complications         
Radius fracture * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olaparib (BRCA1/2 +ve) Placebo (BRCA1/2 +ve) Olaparib (BRCA1/2 -ve) Placebo (BRCA1/2 -ve)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/74 (86.49%)   33/38 (86.84%)   65/72 (90.28%)   30/36 (83.33%) 
Blood and lymphatic system disorders         
Anaemia * 1  13/74 (17.57%)  2/38 (5.26%)  15/72 (20.83%)  1/36 (2.78%) 
Leukopenia * 1  4/74 (5.41%)  0/38 (0.00%)  3/72 (4.17%)  0/36 (0.00%) 
Lymphopenia * 1  2/74 (2.70%)  0/38 (0.00%)  6/72 (8.33%)  0/36 (0.00%) 
Neutropenia * 1  4/74 (5.41%)  4/38 (10.53%)  8/72 (11.11%)  3/36 (8.33%) 
Thrombocytopenia * 1  2/74 (2.70%)  0/38 (0.00%)  4/72 (5.56%)  0/36 (0.00%) 
Anaemia macrocytic * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Leukocytosis * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Microcytic anaemia * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Neutrophilia * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Cardiac disorders         
Palpitations * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Tachycardia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Angina pectoris * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Sinus tachycardia * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Ear and labyrinth disorders         
Tinnitus * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Vertigo * 1  1/74 (1.35%)  0/38 (0.00%)  4/72 (5.56%)  1/36 (2.78%) 
Sudden hearing loss * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Endocrine disorders         
Hypothyroidism * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Eye disorders         
Dry eye * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Eye irritation * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Gastrointestinal disorders         
Abdominal distension * 1  0/74 (0.00%)  1/38 (2.63%)  3/72 (4.17%)  1/36 (2.78%) 
Abdominal pain * 1  8/74 (10.81%)  11/38 (28.95%)  6/72 (8.33%)  6/36 (16.67%) 
Abdominal pain upper * 1  7/74 (9.46%)  0/38 (0.00%)  4/72 (5.56%)  2/36 (5.56%) 
Aphthous ulcer * 1  1/74 (1.35%)  1/38 (2.63%)  0/0  0/0 
Constipation * 1  9/74 (12.16%)  6/38 (15.79%)  9/72 (12.50%)  2/36 (5.56%) 
Diarrhoea * 1  10/74 (13.51%)  5/38 (13.16%)  12/72 (16.67%)  2/36 (5.56%) 
Dry mouth * 1  4/74 (5.41%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Dyspepsia * 1  2/74 (2.70%)  2/38 (5.26%)  2/72 (2.78%)  1/36 (2.78%) 
Dysphagia * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Flatulence * 1  2/74 (2.70%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Gastrooesophageal reflux disease * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Nausea * 1  29/74 (39.19%)  4/38 (10.53%)  30/72 (41.67%)  3/36 (8.33%) 
Odynophagia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Stomatitis * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Vomiting * 1  8/74 (10.81%)  4/38 (10.53%)  6/72 (8.33%)  1/36 (2.78%) 
Abdominal discomfort * 1  0/74 (0.00%)  0/38 (0.00%)  2/72 (2.78%)  0/36 (0.00%) 
Abnormal faeces * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Frequent bowel movements * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Gastritis * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Oesophageal pain * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Oesophagitis * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Paraesthesia oral * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
General disorders         
Asthenia * 1  18/74 (24.32%)  3/38 (7.89%)  15/72 (20.83%)  2/36 (5.56%) 
Axillary pain * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Chest pain * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Fatigue * 1  13/74 (17.57%)  5/38 (13.16%)  13/72 (18.06%)  2/36 (5.56%) 
Illness * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Mucosal inflammation * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Oedema peripheral * 1  1/74 (1.35%)  1/38 (2.63%)  1/72 (1.39%)  2/36 (5.56%) 
Pyrexia * 1  1/74 (1.35%)  0/38 (0.00%)  3/72 (4.17%)  1/36 (2.78%) 
Sluggishness * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Complication associated with device * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Gait disturbance * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Influenza like illness * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Oedema * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Xerosis * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Immune system disorders         
Transplant rejection * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Infections and infestations         
Bronchitis * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
COVID-19 * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Cystitis * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Gastroenteritis cryptosporidial * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Genital herpes * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Gingivitis * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Herpes zoster * 1  0/74 (0.00%)  2/38 (5.26%)  0/72 (0.00%)  1/36 (2.78%) 
Hordeolum * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Influenza * 1  2/74 (2.70%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Oral herpes * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Pharyngitis * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Pleural infection * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Rhinitis * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Sinusitis * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Skin infection * 1  2/74 (2.70%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Tooth abscess * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Urinary tract infection * 1  2/74 (2.70%)  4/38 (10.53%)  3/72 (4.17%)  0/36 (0.00%) 
Abscess jaw * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Nasopharyngitis * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  1/36 (2.78%) 
Otitis media * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Upper respiratory tract infection * 1  0/74 (0.00%)  0/38 (0.00%)  2/72 (2.78%)  1/36 (2.78%) 
Injury, poisoning and procedural complications         
Contusion * 1  2/74 (2.70%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Fall * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Rib fracture * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Eye contusion * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Foot fracture * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Hand fracture * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Investigations         
Alanine aminotransferase increased * 1  3/74 (4.05%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Aspartate aminotransferase increased * 1  2/74 (2.70%)  0/38 (0.00%)  1/72 (1.39%)  1/36 (2.78%) 
Blood albumin decreased * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Blood alkaline phosphatase increased * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Blood bilirubin increased * 1  1/74 (1.35%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Blood creatinine increased * 1  4/74 (5.41%)  1/38 (2.63%)  4/72 (5.56%)  0/36 (0.00%) 
Blood urea increased * 1  2/74 (2.70%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Creatinine renal clearance decreased * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Gamma-glutamyltransferase increased * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Lymphocyte count decreased * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Neutrophil count decreased * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Platelet count decreased * 1  2/74 (2.70%)  0/38 (0.00%)  3/72 (4.17%)  0/36 (0.00%) 
Weight decreased * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Glomerular filtration rate decreased * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Hepatic enzyme increased * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Weight increased * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
White blood cell count decreased * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  2/74 (2.70%)  1/38 (2.63%)  7/72 (9.72%)  1/36 (2.78%) 
Hypercholesterolaemia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Hyperglycaemia * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Hypermagnesaemia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Hyperuricaemia * 1  0/74 (0.00%)  1/38 (2.63%)  1/72 (1.39%)  1/36 (2.78%) 
Hypocalcaemia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Hypokalaemia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Hypomagnesaemia * 1  1/74 (1.35%)  1/38 (2.63%)  0/72 (0.00%)  1/36 (2.78%) 
Hyponatraemia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Folate deficiency * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Hyperchloraemia * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Hypernatraemia * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/74 (0.00%)  3/38 (7.89%)  2/72 (2.78%)  4/36 (11.11%) 
Arthritis * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Back pain * 1  2/74 (2.70%)  1/38 (2.63%)  2/72 (2.78%)  1/36 (2.78%) 
Bone pain * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Flank pain * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Hypercreatinaemia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Muscle spasms * 1  4/74 (5.41%)  1/38 (2.63%)  2/72 (2.78%)  0/36 (0.00%) 
Muscular weakness * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Musculoskeletal discomfort * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Musculoskeletal pain * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Myalgia * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Osteoporosis * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Pain in extremity * 1  0/74 (0.00%)  2/38 (5.26%)  2/72 (2.78%)  0/36 (0.00%) 
Intervertebral disc protrusion * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Musculoskeletal chest pain * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Neck pain * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Spinal pain * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast neoplasm * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Oesophageal squamous cell carcinoma * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Basal cell carcinoma * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Nervous system disorders         
Bell's palsy * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Dizziness * 1  4/74 (5.41%)  1/38 (2.63%)  3/72 (4.17%)  1/36 (2.78%) 
Dysgeusia * 1  3/74 (4.05%)  1/38 (2.63%)  1/72 (1.39%)  0/36 (0.00%) 
Headache * 1  6/74 (8.11%)  1/38 (2.63%)  3/72 (4.17%)  2/36 (5.56%) 
Neuropathy peripheral * 1  1/74 (1.35%)  2/38 (5.26%)  2/72 (2.78%)  1/36 (2.78%) 
Neurotoxicity * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Paraesthesia * 1  2/74 (2.70%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Peripheral sensory neuropathy * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Polyneuropathy * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Sciatica * 1  1/74 (1.35%)  0/38 (0.00%)  2/72 (2.78%)  0/36 (0.00%) 
Syncope * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Tremor * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Anosmia * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Hypoaesthesia * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Post herpetic neuralgia * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Taste disorder * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Psychiatric disorders         
Insomnia * 1  2/74 (2.70%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Dyssomnia * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Emotional disorder * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Mental disorder * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Mood swings * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Renal and urinary disorders         
Haematuria * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Dysuria * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Renal Failure * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Urinary incontinence * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Reproductive system and breast disorders         
Breast pain * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Ovarian vein thrombosis * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Vaginal haemorrhage * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Vulvovaginal dryness * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  5/74 (6.76%)  1/38 (2.63%)  5/72 (6.94%)  2/36 (5.56%) 
Dysphonia * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Dyspnoea * 1  7/74 (9.46%)  2/38 (5.26%)  7/72 (9.72%)  0/36 (0.00%) 
Oropharyngeal pain * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Rhinorrhoea * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Epistaxis * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Nasal dryness * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Respiratory tract congestion * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  1/74 (1.35%)  3/38 (7.89%)  2/72 (2.78%)  0/36 (0.00%) 
Dry skin * 1  2/74 (2.70%)  0/38 (0.00%)  2/72 (2.78%)  1/36 (2.78%) 
Hyperhidrosis * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Pruritus * 1  1/74 (1.35%)  2/38 (5.26%)  0/72 (0.00%)  1/36 (2.78%) 
Rash * 1  1/74 (1.35%)  1/38 (2.63%)  2/72 (2.78%)  1/36 (2.78%) 
Rash maculo-papular * 1  1/74 (1.35%)  0/38 (0.00%)  0/72 (0.00%)  0/36 (0.00%) 
Rash pruritic * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Skin lesion * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Urticaria * 1  0/74 (0.00%)  1/38 (2.63%)  0/72 (0.00%)  0/36 (0.00%) 
Blister * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Erythema * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  1/36 (2.78%) 
Nail disorder * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  1/36 (2.78%) 
Skin reaction * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Vascular disorders         
Hot flush * 1  2/74 (2.70%)  2/38 (5.26%)  0/72 (0.00%)  0/36 (0.00%) 
Hypertension * 1  2/74 (2.70%)  1/38 (2.63%)  1/72 (1.39%)  3/36 (8.33%) 
Hypotension * 1  1/74 (1.35%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Cyanosis * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
Flushing * 1  0/74 (0.00%)  0/38 (0.00%)  0/72 (0.00%)  3/36 (8.33%) 
Varicose vein * 1  0/74 (0.00%)  0/38 (0.00%)  1/72 (1.39%)  0/36 (0.00%) 
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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.
No unpublished information may be disclosed without prior written approval from AstraZeneca.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Head
Organization: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-94 79
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03106987    
Other Study ID Numbers: D0816C00014
First Submitted: March 24, 2017
First Posted: April 11, 2017
Results First Submitted: February 15, 2022
Results First Posted: April 19, 2022
Last Update Posted: October 7, 2022