Trial Outcomes & Findings for Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer (NCT NCT04330040)
NCT ID: NCT04330040
Last Updated: 2025-03-10
Results Overview
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
202 participants
Primary outcome timeframe
Baseline to EOT (approximately 6 months)
Results posted on
2025-03-10
Participant Flow
Participants who were prescribed olaparib by an independent clinical judgement of investigator in his/her routine practice based on locally approved prescribing information were eligible for screening under this study.
Participant milestones
| Measure |
Ovarian Cancer
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian Cancer and Breast Cancer
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
|---|---|---|---|
|
Overall Study
STARTED
|
163
|
38
|
1
|
|
Overall Study
COMPLETED
|
104
|
18
|
1
|
|
Overall Study
NOT COMPLETED
|
59
|
20
|
0
|
Reasons for withdrawal
| Measure |
Ovarian Cancer
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian Cancer and Breast Cancer
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
|---|---|---|---|
|
Overall Study
Other: Adverse event
|
5
|
0
|
0
|
|
Overall Study
Disease progression
|
38
|
10
|
0
|
|
Overall Study
Physician Decision
|
5
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Death
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
0
|
|
Overall Study
Other: Increased QTc interval and clinical progression found
|
0
|
1
|
0
|
|
Overall Study
Other: Progressive disease (no confirming documents)
|
0
|
1
|
0
|
|
Overall Study
Other: Disease progression
|
1
|
0
|
0
|
|
Overall Study
Other: Due to anemia the investigator decided not to continue
|
1
|
0
|
0
|
|
Overall Study
Other: Due to disease progression and could not tolerate the dose
|
1
|
0
|
0
|
|
Overall Study
Enrolled and did not receive study drug (not included in Safety Analysis Set)
|
2
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ovarian Cancer
n=163 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian Cancer and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Child Bearing Potential
Yes
|
1 Participants
n=163 Participants
|
12 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
13 Participants
n=202 Participants
|
|
Child Bearing Potential
No
|
162 Participants
n=163 Participants
|
26 Participants
n=38 Participants
|
1 Participants
n=1 Participants
|
189 Participants
n=202 Participants
|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 8.78 • n=163 Participants
|
44.3 years
STANDARD_DEVIATION 11.85 • n=38 Participants
|
57.0 years
STANDARD_DEVIATION NA • n=1 Participants
|
51.5 years
STANDARD_DEVIATION 10.01 • n=202 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=163 Participants
|
38 Participants
n=38 Participants
|
1 Participants
n=1 Participants
|
202 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=163 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=202 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index
|
26.204 kg/m2
STANDARD_DEVIATION 4.5366 • n=163 Participants
|
24.699 kg/m2
STANDARD_DEVIATION 4.7282 • n=38 Participants
|
21.210 kg/m2
STANDARD_DEVIATION NA • n=1 Participants
|
25.896 kg/m2
STANDARD_DEVIATION 4.6000 • n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IA
|
4 Participants
n=163 Participants
|
2 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
6 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IB
|
0 Participants
n=163 Participants
|
1 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IC
|
5 Participants
n=163 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IIA
|
1 Participants
n=163 Participants
|
3 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
4 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IIB
|
2 Participants
n=163 Participants
|
1 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IIIA
|
12 Participants
n=163 Participants
|
3 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
15 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IIIB
|
6 Participants
n=163 Participants
|
3 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
9 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IIIC
|
60 Participants
n=163 Participants
|
9 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
69 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IVA
|
42 Participants
n=163 Participants
|
10 Participants
n=38 Participants
|
1 Participants
n=1 Participants
|
53 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Stage IVB
|
29 Participants
n=163 Participants
|
6 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
35 Participants
n=202 Participants
|
|
Stage/FIGO Stage of Cancer at Screening
Missing
|
2 Participants
n=163 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=202 Participants
|
|
Previous Cancer Therapy
1 cancer therapy regimen
|
2 Participants
n=163 Participants
|
8 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
10 Participants
n=202 Participants
|
|
Previous Cancer Therapy
2 cancer therapy regimens
|
55 Participants
n=163 Participants
|
10 Participants
n=38 Participants
|
1 Participants
n=1 Participants
|
66 Participants
n=202 Participants
|
|
Previous Cancer Therapy
More than 2 cancer therapy regimens
|
106 Participants
n=163 Participants
|
19 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
125 Participants
n=202 Participants
|
|
Previous Cancer Therapy
No
|
0 Participants
n=163 Participants
|
1 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=202 Participants
|
|
WHO Performance Status
Normal activity
|
157 Participants
n=163 Participants
|
38 Participants
n=38 Participants
|
1 Participants
n=1 Participants
|
196 Participants
n=202 Participants
|
|
WHO Performance Status
Restricted activity
|
6 Participants
n=163 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
6 Participants
n=202 Participants
|
|
WHO Performance Status
In bed less than or equal to 50% of the time
|
0 Participants
n=163 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=202 Participants
|
|
WHO Performance Status
In bed more than 50% of the time
|
0 Participants
n=163 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=202 Participants
|
|
WHO Performance Status
100% bedridden
|
0 Participants
n=163 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=202 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOT (approximately 6 months)Population: The safety analysis set included all participants who received the study drug (200 overall).
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
n=200 Participants
All participants included in this analysis
|
|---|---|---|---|---|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Basophils Absolute Count · EOT Normal
|
72 Participants
|
12 Participants
|
1 Participants
|
85 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Basophils Absolute Count · EOT Above Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Basophils Absolute Count · EOT Below Normal
|
41 Participants
|
10 Participants
|
0 Participants
|
51 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Basophils Absolute Count · EOT Missing
|
48 Participants
|
16 Participants
|
0 Participants
|
64 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Eosinophils Absolute Count · EOT Above Normal
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Eosinophils Absolute Count · EOT Normal
|
90 Participants
|
20 Participants
|
1 Participants
|
111 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Eosinophils Absolute Count · EOT Below Normal
|
21 Participants
|
3 Participants
|
0 Participants
|
24 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Eosinophils Absolute Count · EOT Missing
|
48 Participants
|
15 Participants
|
0 Participants
|
63 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Leucocytes WBC · EOT Above Normal
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Leucocytes WBC · EOT Normal
|
101 Participants
|
17 Participants
|
1 Participants
|
119 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Leucocytes WBC · EOT Below Normal
|
27 Participants
|
8 Participants
|
0 Participants
|
35 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Leucocytes WBC · EOT Missing
|
31 Participants
|
12 Participants
|
0 Participants
|
43 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Lymphocytes Absolute Count · EOT Above Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Lymphocytes Absolute Count · EOT Normal
|
79 Participants
|
10 Participants
|
0 Participants
|
89 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Lymphocytes Absolute Count · EOT Below Normal
|
51 Participants
|
16 Participants
|
1 Participants
|
68 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Lymphocytes Absolute Count · EOT Missing
|
31 Participants
|
12 Participants
|
0 Participants
|
43 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Monocytes Absolute Count · EOT Above Normal
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Monocytes Absolute Count · EOT Normal
|
84 Participants
|
14 Participants
|
1 Participants
|
99 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Monocytes Absolute Count · EOT Below Normal
|
26 Participants
|
8 Participants
|
0 Participants
|
34 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Monocytes Absolute Count · EOT Missing
|
48 Participants
|
15 Participants
|
0 Participants
|
63 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Neutrophils Absolute Count · EOT Above Normal
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Neutrophils Absolute Count · EOT Normal
|
107 Participants
|
19 Participants
|
1 Participants
|
127 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Neutrophils Absolute Count · EOT Below Normal
|
21 Participants
|
6 Participants
|
0 Participants
|
27 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Neutrophils Absolute Count · EOT Missing
|
31 Participants
|
12 Participants
|
0 Participants
|
43 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Platelets · EOT Above Normal
|
18 Participants
|
6 Participants
|
1 Participants
|
25 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Platelets · EOT Normal
|
69 Participants
|
13 Participants
|
0 Participants
|
82 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Platelets · EOT Below Normal
|
43 Participants
|
7 Participants
|
0 Participants
|
50 Participants
|
|
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Platelets · EOT Missing
|
31 Participants
|
12 Participants
|
0 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOT (approximately 6 months)Population: The safety analysis set included all participants who received the study drug (200 overall).
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
n=200 Participants
All participants included in this analysis
|
|---|---|---|---|---|
|
Haematology: Haemoglobin Parameters
EOT Above Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Haematology: Haemoglobin Parameters
EOT Normal
|
15 Participants
|
5 Participants
|
0 Participants
|
20 Participants
|
|
Haematology: Haemoglobin Parameters
EOT Below Normal
|
115 Participants
|
21 Participants
|
1 Participants
|
137 Participants
|
|
Haematology: Haemoglobin Parameters
EOT Missing
|
31 Participants
|
12 Participants
|
0 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOT (approximately 6 months)Population: The safety analysis set included all participants who received the study drug (200 overall).
The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
n=200 Participants
All participants included in this analysis
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Basophils Absolute Count
|
13 Participants
|
5 Participants
|
0 Participants
|
18 Participants
|
|
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Eosinophils Absolute Count
|
8 Participants
|
2 Participants
|
0 Participants
|
10 Participants
|
|
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Leucocytes WBC
|
17 Participants
|
6 Participants
|
0 Participants
|
23 Participants
|
|
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Lymphocytes Absolute Count
|
20 Participants
|
8 Participants
|
1 Participants
|
29 Participants
|
|
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Monocytes Absolute Count
|
21 Participants
|
6 Participants
|
0 Participants
|
27 Participants
|
|
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Neutrophils Absolute Count
|
9 Participants
|
5 Participants
|
0 Participants
|
14 Participants
|
|
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Platelets
|
23 Participants
|
4 Participants
|
0 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOT (approximately 6 months)Population: The safety analysis set included all participants who received the study drug (200 overall).
The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
n=200 Participants
All participants included in this analysis
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT
|
17 Participants
|
11 Participants
|
0 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOT (approximately 6 months)Population: The safety analysis set included all participants who received the study drug (200 overall).
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
All participants included in this analysis
|
|---|---|---|---|---|
|
Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline to EOT (approximately 6 months)Population: Safety Analysis Set
Abnormal clinically significant results at Baseline and EOT are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
All participants included in this analysis
|
|---|---|---|---|---|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · Cardiovascular
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · Abdomen
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · Lymph Nodes
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · Musculoskeletal system
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · No response
|
161 Participants
|
37 Participants
|
1 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · Physical Examination Status
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · General Appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · Abdomen
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · Lymph Nodes
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · Respiratory
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · Cardiovascular
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · Physical Examination Status
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · General Appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at Baseline · Respiratory
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · Musculoskeletal system
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal Clinically Significant result at End of Treatment · No response
|
157 Participants
|
35 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline to EOT (approximately 6 months)Population: The safety analysis set included all participants who received the study drug (200 overall).
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
All participants included in this analysis
|
|---|---|---|---|---|
|
Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline and End of study visit (200 days)Population: The safety analysis set included all participants who received the study drug (200 overall).
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Outcome measures
| Measure |
Ovarian
n=161 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian and Breast Cancer
n=1 Participants
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Cancer Type: Overall
n=200 Participants
All participants included in this analysis
|
|---|---|---|---|---|
|
WHO Performance Status
Baseline · Normal activity
|
155 Participants
|
38 Participants
|
1 Participants
|
194 Participants
|
|
WHO Performance Status
Baseline · Restricted activity
|
6 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
|
WHO Performance Status
Baseline · In bed less than or equal to 50% of the time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
WHO Performance Status
End of Study · Normal activity
|
92 Participants
|
12 Participants
|
0 Participants
|
104 Participants
|
|
WHO Performance Status
End of Study · Restricted activity
|
7 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
|
WHO Performance Status
End of Study · In bed less than or equal to 50% of the time
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Ovarian Cancer
Serious events: 24 serious events
Other events: 148 other events
Deaths: 3 deaths
Breast Cancer
Serious events: 7 serious events
Other events: 30 other events
Deaths: 3 deaths
Both Ovarian Cancer and Breast Cancer
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ovarian Cancer
n=161 participants at risk
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 participants at risk
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian Cancer and Breast Cancer
n=1 participants at risk
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.5%
12/161 • Number of events 14 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
5.3%
2/38 • Number of events 2 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
5.3%
2/38 • Number of events 2 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Malaria
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Cardiac disorders
Pericardial effusion
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Eye disorders
Retinal vascular occlusion
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
100.0%
1/1 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
3/161 • Number of events 3 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
General disorders
Asthenia
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
General disorders
Death
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Infections and infestations
COVID-19
|
2.5%
4/161 • Number of events 4 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Infections and infestations
Dengue fever
|
1.2%
2/161 • Number of events 2 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Investigations
Aspiration pleural cavity
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Nervous system disorders
Ischaemic stroke
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.62%
1/161 • Number of events 1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
Other adverse events
| Measure |
Ovarian Cancer
n=161 participants at risk
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Breast Cancer
n=38 participants at risk
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
Both Ovarian Cancer and Breast Cancer
n=1 participants at risk
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.9%
82/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
36.8%
14/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.7%
35/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
13.2%
5/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.2%
18/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
7.9%
3/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.1%
13/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Nausea
|
20.5%
33/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
7.9%
3/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
27/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
10.5%
4/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.2%
18/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
5.3%
2/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
14/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
2.6%
1/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
10/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
10.5%
4/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
General disorders
Fatigue
|
15.5%
25/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
7.9%
3/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
General disorders
Asthenia
|
8.1%
13/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
7.9%
3/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
100.0%
1/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
General disorders
Pyrexia
|
9.9%
16/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
5.3%
2/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Infections and infestations
COVID-19
|
5.0%
8/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
5.3%
2/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.2%
18/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
13.2%
5/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
16/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
7.9%
3/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Nervous system disorders
Headache
|
5.6%
9/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
10.5%
4/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
10/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
9/161 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/38 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
0.00%
0/1 • 6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'. Adverse events for the Safety Analysis Set are presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER