A Phase 4 interventional study of Olaparib in Ovarian Cancer and Breast Cancer, sponsored by AstraZeneca. Completed at 16 sites in India. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA (BReast CAncer gene) 1/2 Mutation
A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA(BReast CAncer gene)1/2 Mutation As per recommendation from DCGI(Drug Controller general of of India), the current phase-IV study is planned with the aim to assess the safety in Indian subjects receiving olaparib as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. This study attempts to descriptively elucidate the safety of Olaparib in Indian subjects receiving olaparib as per the Indian regulatory approved indications in India. The data obtained from the present study will help to understand the safety profile of olaparib in Indian patients.
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This study's enrollment of 202 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Subjects receiving olaparib for the following indications in ovarian cancer:
for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment
Exclusion Criteria:
Intervention: Drug: Olaparib
Drug: Olaparib
Tablet
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
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
Time frame: Baseline to EOT (approximately 6 months)
Haematology: Haemoglobin Parameters
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
Time frame: Baseline to EOT (approximately 6 months)
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
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
Time frame: Baseline to EOT (approximately 6 months)
Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT
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
Time frame: Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator
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
Time frame: Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
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.
Time frame: Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator
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
Time frame: Baseline to EOT (approximately 6 months)
WHO Performance Status
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.
Time frame: Baseline and End of study visit (200 days)
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.
| Milestone | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer |
|---|---|---|---|
| Started | 163 | 38 | 1 |
| Completed | 104 | 18 | 1 |
| Not completed | 59 | 20 | 0 |
| Withdrew: Other: adverse event | 5 | 0 | 0 |
| Withdrew: Disease progression | 38 | 10 | 0 |
| Withdrew: Physician decision | 5 | 3 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 |
| Withdrew: Death | 2 | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 3 | 0 |
| Withdrew: Other: increased qtc interval and clinical progression found | 0 | 1 | 0 |
| Withdrew: Other: progressive disease (no confirming documents) | 0 | 1 | 0 |
| Withdrew: Other: disease progression | 1 | 0 | 0 |
| Withdrew: Other: due to anemia the investigator decided not to continue | 1 | 0 | 0 |
| Withdrew: Other: due to disease progression and could not tolerate the dose | 1 | 0 | 0 |
| Withdrew: Enrolled and did not receive study drug (not included in safety analysis set) | 2 | 0 | 0 |
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
| Participants | Ovarian | Breast Cancer | Both Ovarian and Breast Cancer | Cancer Type: Overall |
|---|---|---|---|---|
| Basophils Absolute Count — EOT Above Normal | 0 | 0 | 0 | 0 |
| Basophils Absolute Count — EOT Normal | 72 | 12 | 1 | 85 |
| Basophils Absolute Count — EOT Below Normal | 41 | 10 | 0 | 51 |
| Basophils Absolute Count — EOT Missing | 48 | 16 | 0 | 64 |
| Eosinophils Absolute Count — EOT Above Normal | 2 | 0 | 0 | 2 |
| Eosinophils Absolute Count — EOT Normal | 90 | 20 | 1 | 111 |
| Eosinophils Absolute Count — EOT Below Normal | 21 | 3 | 0 | 24 |
| Eosinophils Absolute Count — EOT Missing | 48 | 15 | 0 | 63 |
| Leucocytes WBC — EOT Above Normal | 2 | 1 | 0 | 3 |
| Leucocytes WBC — EOT Normal | 101 | 17 | 1 | 119 |
| Leucocytes WBC — EOT Below Normal | 27 | 8 | 0 | 35 |
| Leucocytes WBC — EOT Missing | 31 | 12 | 0 | 43 |
| Lymphocytes Absolute Count — EOT Above Normal | 0 | 0 | 0 | 0 |
| Lymphocytes Absolute Count — EOT Normal | 79 | 10 | 0 | 89 |
| Lymphocytes Absolute Count — EOT Below Normal | 51 | 16 | 1 | 68 |
| Lymphocytes Absolute Count — EOT Missing | 31 | 12 | 0 | 43 |
| Monocytes Absolute Count — EOT Above Normal | 3 | 1 | 0 | 4 |
| Monocytes Absolute Count — EOT Normal | 84 | 14 | 1 | 99 |
| Monocytes Absolute Count — EOT Below Normal | 26 | 8 | 0 | 34 |
| Monocytes Absolute Count — EOT Missing | 48 | 15 | 0 | 63 |
| Neutrophils Absolute Count — EOT Above Normal | 2 | 1 | 0 | 3 |
| Neutrophils Absolute Count — EOT Normal | 107 | 19 | 1 | 127 |
| Neutrophils Absolute Count — EOT Below Normal | 21 | 6 | 0 | 27 |
| Neutrophils Absolute Count — EOT Missing | 31 | 12 | 0 | 43 |
| Platelets — EOT Above Normal | 18 | 6 | 1 | 25 |
| Platelets — EOT Normal | 69 | 13 | 0 | 82 |
| Platelets — EOT Below Normal | 43 | 7 | 0 | 50 |
| Platelets — EOT Missing | 31 | 12 | 0 | 43 |
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
| Participants | Ovarian Cancer | Breast Cancer | Both Ovarian and Breast Cancer | Cancer Type: Overall |
|---|---|---|---|---|
| EOT Above Normal | 0 | 0 | 0 | 0 |
| EOT Normal | 15 | 5 | 0 | 20 |
| EOT Below Normal | 115 | 21 | 1 | 137 |
| EOT Missing | 31 | 12 | 0 | 43 |
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
| Participants | Ovarian Cancer | Breast Cancer | Both Ovarian and Breast Cancer | Cancer Type: Overall |
|---|---|---|---|---|
| Basophils Absolute Count | 13 | 5 | 0 | 18 |
| Eosinophils Absolute Count | 8 | 2 | 0 | 10 |
| Leucocytes WBC | 17 | 6 | 0 | 23 |
| Lymphocytes Absolute Count | 20 | 8 | 1 | 29 |
| Monocytes Absolute Count | 21 | 6 | 0 | 27 |
| Neutrophils Absolute Count | 9 | 5 | 0 | 14 |
| Platelets | 23 | 4 | 0 | 27 |
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
| Participants | Ovarian Cancer | Breast Cancer | Both Ovarian and Breast Cancer | Cancer Type: Overall |
|---|---|---|---|---|
| Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | 17 | 11 | 0 | 28 |
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
| Participants | Ovarian Cancer | Breast Cancer | Both Ovarian and Breast Cancer |
|---|---|---|---|
| Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator | 0 | 0 | 0 |
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.
| Participants | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer |
|---|---|---|---|
| Abnormal Clinically Significant result at Baseline — Physical Examination Status | 0 | 0 | 0 |
| Abnormal Clinically Significant result at Baseline — General Appearance | 0 | 0 | 0 |
| Abnormal Clinically Significant result at Baseline — Respiratory | 0 | 0 | 0 |
| Abnormal Clinically Significant result at Baseline — Cardiovascular | 0 | 0 | 0 |
| Abnormal Clinically Significant result at Baseline — Abdomen | 0 | 0 | 0 |
| Abnormal Clinically Significant result at Baseline — Lymph Nodes | 0 | 0 | 0 |
| Abnormal Clinically Significant result at Baseline — Musculoskeletal system | 0 | 1 | 0 |
| Abnormal Clinically Significant result at Baseline — No response | 161 | 37 | 1 |
| Abnormal Clinically Significant result at End of Treatment — Physical Examination Status | 2 | 1 | 0 |
| Abnormal Clinically Significant result at End of Treatment — General Appearance | 0 | 0 | 0 |
| Abnormal Clinically Significant result at End of Treatment — Respiratory | 1 | 1 | 0 |
| Abnormal Clinically Significant result at End of Treatment — Cardiovascular | 0 | 0 | 0 |
| Abnormal Clinically Significant result at End of Treatment — Abdomen | 1 | 0 | 0 |
| Abnormal Clinically Significant result at End of Treatment — Lymph Nodes | 0 | 1 | 0 |
| Abnormal Clinically Significant result at End of Treatment — Musculoskeletal system | 0 | 0 | 0 |
| Abnormal Clinically Significant result at End of Treatment — No response | 157 | 35 | 1 |
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
| Participants | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer |
|---|---|---|---|
| Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator | 0 | 0 | 0 |
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.
| Participants | Ovarian Cancer | Breast Cancer | Both Ovarian and Breast Cancer | Cancer Type: Overall |
|---|---|---|---|---|
| Baseline — Normal activity | 155 | 38 | 1 | 194 |
| Baseline — Restricted activity | 6 | 0 | 0 | 6 |
| Baseline — In bed less than or equal to 50% of the time | 0 | 0 | 0 | 0 |
| End of Study — Normal activity | 92 | 12 | 0 | 104 |
| End of Study — Restricted activity | 7 | 1 | 0 | 8 |
| End of Study — In bed less than or equal to 50% of the time | 1 | 0 | 0 | 1 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ovarian Cancer | 3/161 (1.9%) | 24/161 (14.9%) | 148/161 (91.9%) |
| Breast Cancer | 3/38 (7.9%) | 7/38 (18.4%) | 30/38 (78.9%) |
| Both Ovarian Cancer and Breast Cancer | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Event | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer |
|---|---|---|---|
| Retinal vascular occlusionEye disorders | 0/161 | 0/38 | 1/1 |
| AnaemiaBlood and lymphatic system disorders | 12/161 | 2/38 | 0/1 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/161 | 2/38 | 0/1 |
| CoagulopathyBlood and lymphatic system disorders | 0/161 | 1/38 | 0/1 |
| Increased tendency to bruiseBlood and lymphatic system disorders | 0/161 | 1/38 | 0/1 |
| NeutropeniaBlood and lymphatic system disorders | 0/161 | 1/38 | 0/1 |
| Abdominal painGastrointestinal disorders | 3/161 | 1/38 | 0/1 |
| Abdominal distensionGastrointestinal disorders | 0/161 | 1/38 | 0/1 |
| ConstipationGastrointestinal disorders | 0/161 | 1/38 | 0/1 |
| AstheniaGeneral disorders | 1/161 | 1/38 | 0/1 |
| Event | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer |
|---|---|---|---|
| AstheniaGeneral disorders | 13/161 | 3/38 | 1/1 |
| AnaemiaBlood and lymphatic system disorders | 82/161 | 14/38 | 0/1 |
| ThrombocytopeniaBlood and lymphatic system disorders | 35/161 | 5/38 | 0/1 |
| NauseaGastrointestinal disorders | 33/161 | 3/38 | 0/1 |
| VomitingGastrointestinal disorders | 27/161 | 4/38 | 0/1 |
| FatigueGeneral disorders | 25/161 | 3/38 | 0/1 |
| Decreased appetiteMetabolism and nutrition disorders | 18/161 | 5/38 | 0/1 |
| LeukopeniaBlood and lymphatic system disorders | 18/161 | 3/38 | 0/1 |
| DiarrhoeaGastrointestinal disorders | 18/161 | 2/38 | 0/1 |
| ConstipationGastrointestinal disorders | 10/161 | 4/38 | 0/1 |
All enrolled participants
| Age, Continuous(years) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| Mean | 53.2 ± 8.78 | 44.3 ± 11.85 | 57.0 ± NA | 51.5 ± 10.01 |
| Sex: Female, Male(Participants) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| Female | 163 | 38 | 1 | 202 |
| Male | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Body mass index(kg/m2) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| Mean | 26.204 ± 4.5366 | 24.699 ± 4.7282 | 21.210 ± NA | 25.896 ± 4.6000 |
| Child Bearing Potential(Participants) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| Yes | 1 | 12 | 0 | 13 |
| No | 162 | 26 | 1 | 189 |
| Stage/FIGO Stage of Cancer at Screening(Participants) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| Stage IA | 4 | 2 | 0 | 6 |
| Stage IB | 0 | 1 | 0 | 1 |
| Stage IC | 5 | 0 | 0 | 5 |
| Stage IIA | 1 | 3 | 0 | 4 |
| Stage IIB | 2 | 1 | 0 | 3 |
| Stage IIIA | 12 | 3 | 0 | 15 |
| Stage IIIB | 6 | 3 | 0 | 9 |
| Stage IIIC | 60 | 9 | 0 | 69 |
| Stage IVA | 42 | 10 | 1 | 53 |
| Stage IVB | 29 | 6 | 0 | 35 |
| Missing | 2 | 0 | 0 | 2 |
| Previous Cancer Therapy(Participants) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| 1 cancer therapy regimen | 2 | 8 | 0 | 10 |
| 2 cancer therapy regimens | 55 | 10 | 1 | 66 |
| More than 2 cancer therapy regimens | 106 | 19 | 0 | 125 |
| No | 0 | 1 | 0 | 1 |
| WHO Performance Status(Participants) | Ovarian Cancer | Breast Cancer | Both Ovarian Cancer and Breast Cancer | Total |
|---|---|---|---|---|
| Normal activity | 157 | 38 | 1 | 196 |
| Restricted activity | 6 | 0 | 0 | 6 |
| In bed less than or equal to 50% of the time | 0 | 0 | 0 | 0 |
| In bed more than 50% of the time | 0 | 0 | 0 | 0 |
| 100% bedridden | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting information: Study protocol, Sap
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