Trial Outcomes & Findings for Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer (NCT NCT02889900)
NCT ID: NCT02889900
Last Updated: 2022-03-08
Results Overview
The ORR was defined as the percentage of patients with objective response (complete response \[CR\] or partial response \[PR\]) according to RECIST 1.1 and was assessed by ICR. Only patients whose CR/PR response was confirmed by a second scan at least 4 weeks after the initial response, with no evidence of progression between the initial and CR/PR confirmation visit were included. CR: Disappearance of all target lesions (TLs) and non-TLs (NTLS) since baseline; any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of TL, referencing the baseline sum of diameters. Data obtained up until progression, or last evaluable assessment in the absence of progression were included in the assessment of ORR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.
Results posted on
2022-03-08
Participant Flow
Patients with platinum-resistant relapsed high grade serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal carcinoma who had received at least 3 prior lines of therapy for advanced ovarian cancer were recruited to 25 study centers in the United States in this single arm, open-label Phase IIb study.
Patients had no evidence of deleterious or suspected deleterious germline breast cancer susceptibility gene (gBRCA) mutations. Patients had to have measurable disease, defined as ≥1 lesion that could be assessed at baseline by computed tomography / magnetic resonance imaging and be suitable for repeated assessment.
Participant milestones
| Measure |
Cediranib + Olaparib
Patients received a combination of cediranib 30 milligrams (mg) orally once daily (qd) and olaparib 200 mg orally twice daily (bid) until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
Received Treatment
|
60
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Cediranib + Olaparib
Patients received a combination of cediranib 30 milligrams (mg) orally once daily (qd) and olaparib 200 mg orally twice daily (bid) until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Condition under investigation worsened
|
32
|
|
Overall Study
Other
|
5
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Not treated
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Cediranib + Olaparib
n=60 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
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Age, Continuous
|
63.8 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.Population: The evaluable for response (EFR) analysis set included all patients who received at least 1 dose of IP and had measurable disease at baseline according to the independent review of baseline imaging data. RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.
The ORR was defined as the percentage of patients with objective response (complete response \[CR\] or partial response \[PR\]) according to RECIST 1.1 and was assessed by ICR. Only patients whose CR/PR response was confirmed by a second scan at least 4 weeks after the initial response, with no evidence of progression between the initial and CR/PR confirmation visit were included. CR: Disappearance of all target lesions (TLs) and non-TLs (NTLS) since baseline; any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of TL, referencing the baseline sum of diameters. Data obtained up until progression, or last evaluable assessment in the absence of progression were included in the assessment of ORR.
Outcome measures
| Measure |
Cediranib + Olaparib
n=59 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
|
Mean Objective Response Rate (ORR) by Independent Central Review (ICR) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
15.3 percentage of patients
Interval 7.2 to 27.0
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SECONDARY outcome
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.Population: The FAS included all patients who received at least 1 dose of either of the IPs.
The percentage of patients with a response (CR/PR), including patients with both confirmed and unconfirmed responses, based on investigator assessed RECIST 1.1 data is presented. Confirmed responses included patients whose CR/PR response was confirmed by a second scan at least 4 weeks after the initial response, with no evidence of progression between the initial and CR/PR confirmation visit. CR: Disappearance of all TLs and NTLs since baseline; any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of TL, referencing the baseline sum of diameters.
Outcome measures
| Measure |
Cediranib + Olaparib
n=60 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
|
ORR by Investigator Assessment Using RECIST 1.1
|
26.7 percentage of patients
Interval 16.1 to 39.7
|
SECONDARY outcome
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.Population: The EFR set included all patients who received at least 1 dose of IP and had measurable disease at baseline according to the independent review of baseline imaging data. The FAS included all patients who received at least 1 dose of either of the IPs.
DoR was defined as the time from date of first documented response (which was subsequently confirmed) until date of documented progression or death in the absence of disease progression (i.e. date of progression free survival \[PFS\] event or censoring - date of first response + 1). The end of response coincided with the date of progression or death from any cause used for the PFS endpoint. The time of initial response was defined as the latest of the dates used towards the first visit that was CR or PR that was subsequently confirmed. If a patient did not progress following a response, the PFS censoring time was used. The Investigator assessment was based on the FAS and the ICR used the EFR analysis set. The median DoR for each assessment is presented and was calculated using the Kaplan-Meier technique.
Outcome measures
| Measure |
Cediranib + Olaparib
n=60 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
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Median Duration of Response (DoR) by ICR and Investigator Assessment Using RECIST 1.1
ICR assessment (EFR analysis set)
|
36.0 weeks
Interval 24.4 to 45.0
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|
Median Duration of Response (DoR) by ICR and Investigator Assessment Using RECIST 1.1
Investigator assessment (FAS)
|
45.0 weeks
Interval 25.0 to 58.0
|
SECONDARY outcome
Timeframe: From baseline up to 6 months after first doses of IPs. RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.Population: The EFR set included all patients who received at least 1 dose of IP and had measurable disease at baseline according to the independent review of baseline imaging data. The FAS included all patients who received at least 1 dose of either of the IPs.
The DCR was defined as the percentage of patients who had a best overall response of CR, PR or Stable Disease (SD) at 6 months. CR: Disappearance of all TLs and NTLs since baseline; any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of TL, referencing the baseline sum of diameters. SD: Neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase to qualify for progressive disease (PD) (at least a 20% increase in the sum of diameters of TLs with an absolute increase of at least 5 mm and progression of existing NTLs). Patients had to have demonstrated SD for at least 23 weeks following the start of treatment. The Investigator assessment was based on the FAS and the ICR used the EFR analysis set. The percentage of patients with disease control for each assessment is presented.
Outcome measures
| Measure |
Cediranib + Olaparib
n=60 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
|
|---|---|
|
Disease Control Rate (DCR) by ICR and Investigator Assessment Using RECIST 1.1
ICR assessment (EFR analysis set)
|
23.7 percentage of patients
Interval 13.6 to 36.6
|
|
Disease Control Rate (DCR) by ICR and Investigator Assessment Using RECIST 1.1
Investigator assessment (FAS)
|
26.7 percentage of patients
Interval 16.1 to 39.7
|
SECONDARY outcome
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.Population: The FAS included all patients who received at least 1 dose of either of the IPs.
PFS was defined as the time from date of first dose of IP until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from treatment or received another anti-cancer therapy prior to progression (i.e. date of PFS event or censoring - date of first dose + 1). Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. The median PFS, calculated using the Kaplan-Meier technique, is presented for the ICR and the Investigator assessment, both based on the FAS.
Outcome measures
| Measure |
Cediranib + Olaparib
n=60 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
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Median PFS by ICR and Investigator Assessment Using RECIST 1.1
ICR assessment (FAS)
|
5.1 months
Interval 3.5 to 5.5
|
|
Median PFS by ICR and Investigator Assessment Using RECIST 1.1
Investigator assessment (FAS)
|
3.8 months
Interval 3.5 to 6.4
|
SECONDARY outcome
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs).Population: The FAS included all patients who received at least 1 dose of either of the IPs.
The median time to discontinuation of IPs or death was defined as the time from the date of first dose of IP to the earlier of the date of discontinuation of both IPs, or death date. If 1 IP was discontinued before the other, the TDT reflected the time from the date of first dose to the earliest IP discontinuation date. The median TDT was calculated using the Kaplan-Meier technique.
Outcome measures
| Measure |
Cediranib + Olaparib
n=60 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
|
Median Time to Treatment Discontinuation or Death (TDT)
|
3.5 months
Interval 2.7 to 5.1
|
SECONDARY outcome
Timeframe: From baseline until death due to any cause, assessed until primary analysis DCO (8 months after last patient received their first dose of IPs).Population: The FAS included all patients who received at least 1 dose of either of the IPs.
OS was defined as the time from the date of first dose of IP until death due to any cause regardless of whether the patient withdrew from treatment or received another anti-cancer therapy (i.e. date of death or censoring - date of first dose + 1). Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. The median OS was calculated using the Kaplan-Meier technique.
Outcome measures
| Measure |
Cediranib + Olaparib
n=60 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
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Median Overall Survival (OS)
|
13.2 months
Interval 9.4 to 16.4
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SECONDARY outcome
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). EORTC QLQ-C30 assessments were performed at baseline and every 8 weeks relative to first dose until discontinuation of IPs.Population: The FAS included all patients who received at least 1 dose of either of the IPs. Only patients with non-missing baseline and post-baseline data were included in the analysis.
The EORTC QLQ-C30 questionnaire assesses health-related quality of life (HRQoL). The questions are grouped into a global health status/QoL scale, 5 functional scales (physical, role, emotional, cognitive and social), 3 multi-item symptom scales (fatigue, pain, nausea/ vomiting), 5 single items assessing cancer symptoms (dyspnea, loss of appetite, insomnia, constipation, diarrhea), and 1 item on the financial impact of the disease. Each scale/item is scored from 0 to 100. Higher scores on the global health status/QoL scale and functional scales indicate better health status/function. Higher scores on the symptom scales/items indicate a greater symptom burden. A 10-point change in the score was used to identify patients who improved, stayed the same or deteriorated from baseline. The number of patients with a best observed change from baseline response of improved, stayed the same or deteriorated for each EORTC QLQ-C30 scale/item is presented.
Outcome measures
| Measure |
Cediranib + Olaparib
n=36 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
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|---|---|
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Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Financial difficulties: improved
|
2 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Nausea / vomiting: stayed the same
|
19 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Pain: deteriorated
|
6 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Physical functioning: stayed the same
|
24 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Physical functioning: deteriorated
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12 Participants
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Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Role functioning: improved
|
1 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Role functioning: deteriorated
|
17 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Social functioning: stayed the same
|
22 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Appetite loss: improved
|
0 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Appetite loss: stayed the same
|
22 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Appetite loss: deteriorated
|
14 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Cognitive functioning: improved
|
2 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Cognitive functioning: stayed the same
|
23 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Cognitive functioning: deteriorated
|
11 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Constipation: improved
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2 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Constipation: stayed the same
|
27 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Constipation: deteriorated
|
7 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Diarrhea: improved
|
0 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Diarrhea: stayed the same
|
22 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Diarrhea: deteriorated
|
14 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Dyspnea: improved
|
2 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Dyspnea: stayed the same
|
24 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Dyspnea: deteriorated
|
10 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Emotional functioning: improved
|
2 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Emotional functioning: stayed the same
|
31 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Emotional functioning: deteriorated
|
3 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Fatigue: improved
|
4 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Fatigue: stayed the same
|
11 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Fatigue: deteriorated
|
21 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Financial difficulties: stayed the same
|
32 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Financial difficulties: deteriorated
|
2 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Global Health Status / QoL: improved
|
1 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Global Health Status / QoL: stayed the same
|
19 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Global Health Status / QoL: deteriorated
|
16 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Insomnia: improved
|
3 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Insomnia: stayed the same
|
26 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Insomnia: deteriorated
|
7 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Nausea / vomiting: improved
|
4 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Nausea / vomiting: deteriorated
|
13 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Pain: improved
|
9 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Pain: stayed the same
|
21 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Physical functioning: improved
|
0 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Role functioning: stayed the same
|
18 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Social functioning: improved
|
1 Participants
|
|
Best Observed Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 Scales
Social functioning: deteriorated
|
13 Participants
|
SECONDARY outcome
Timeframe: From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). EORTC QLQ-OV28 assessments were performed at baseline and every 8 weeks relative to first dose until discontinuation of IPs.Population: The FAS included all patients who received at least 1 dose of either of the IPs. Only patients with non-missing baseline and post-baseline data were included in the analysis.
The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. The best observed change from baseline is presented for each EORTC QLQ-OV28 scale, where a 10-point change in the score was used to identify patients who improved, stayed the same or deteriorated. The number of patients with a best observed change from baseline response of improved, stayed the same, or deteriorated in the EORTC QLQ-OV28 is presented.
Outcome measures
| Measure |
Cediranib + Olaparib
n=32 Participants
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
|
|---|---|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Abdominal / Gastrointestinal: improved
|
2 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Abdominal / Gastrointestinal: stayed the same
|
18 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Attitude to disease / treatment: improved
|
3 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Body image: improved
|
7 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Body image: stayed the same
|
19 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Body image: deteriorated
|
6 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Chemotherapy side effects: improved
|
1 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Chemotherapy side effects: stayed the same
|
24 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Chemotherapy side effects: deteriorated
|
7 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Hormonal: improved
|
2 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Hormonal: stayed the same
|
25 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Hormonal: deteriorated
|
5 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Other single items: improved
|
1 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Other single items: stayed the same
|
19 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Peripheral neuropathy: improved
|
1 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Peripheral neuropathy: stayed the same
|
24 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Peripheral neuropathy: deteriorated
|
7 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Sexuality: improved
|
2 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Sexuality: stayed the same
|
26 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Sexuality: deteriorated
|
4 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Abdominal / Gastrointestinal: deteriorated
|
12 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Attitude to disease / treatment: stayed the same
|
16 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Attitude to disease / treatment: deteriorated
|
13 Participants
|
|
Best Observed Change From Baseline in EORTC QLQ-OV28
Other single items: deteriorated
|
12 Participants
|
Adverse Events
Cediranib + Olaparib
Serious events: 22 serious events
Other events: 56 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Cediranib + Olaparib
n=60 participants at risk
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Number of events 2 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Cardiac disorders
Angina pectoris
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Endocrine disorders
Hyperparathyroidism
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Number of events 4 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.7%
1/60 • Number of events 2 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
2/60 • Number of events 2 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
General disorders
Oedema peripheral
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Infections and infestations
Sepsis
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Investigations
Blood pressure increased
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Ataxia
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Seizure
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
2/60 • Number of events 2 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
Other adverse events
| Measure |
Cediranib + Olaparib
n=60 participants at risk
Patients received a combination of cediranib 30 mg orally qd and olaparib 200 mg orally bid until objective radiological disease progression, unacceptable toxicity or withdrawal of consent. Dose modification was allowed per protocol-defined guidelines.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
12/60 • Number of events 19 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
6/60 • Number of events 15 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Endocrine disorders
Hypothyroidism
|
15.0%
9/60 • Number of events 9 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
5/60 • Number of events 5 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
20/60 • Number of events 27 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Constipation
|
28.3%
17/60 • Number of events 19 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
40/60 • Number of events 78 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
5/60 • Number of events 5 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
5/60 • Number of events 5 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Nausea
|
65.0%
39/60 • Number of events 50 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
6/60 • Number of events 6 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
6/60 • Number of events 6 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Gastrointestinal disorders
Vomiting
|
38.3%
23/60 • Number of events 38 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
General disorders
Asthenia
|
10.0%
6/60 • Number of events 9 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
General disorders
Fatigue
|
68.3%
41/60 • Number of events 50 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
General disorders
Mucosal inflammation
|
8.3%
5/60 • Number of events 8 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
General disorders
Oedema peripheral
|
15.0%
9/60 • Number of events 11 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
10/60 • Number of events 11 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
6/60 • Number of events 7 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
5/60 • Number of events 6 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Investigations
Blood creatinine increased
|
15.0%
9/60 • Number of events 11 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.7%
7/60 • Number of events 7 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Investigations
Platelet count decreased
|
11.7%
7/60 • Number of events 8 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Investigations
Weight decreased
|
13.3%
8/60 • Number of events 9 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.0%
21/60 • Number of events 24 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
10/60 • Number of events 15 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
5/60 • Number of events 6 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
10/60 • Number of events 12 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
15/60 • Number of events 25 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
12/60 • Number of events 18 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
6/60 • Number of events 8 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
4/60 • Number of events 6 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
5/60 • Number of events 5 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
4/60 • Number of events 4 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
4/60 • Number of events 4 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.7%
7/60 • Number of events 8 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Dizziness
|
11.7%
7/60 • Number of events 8 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Dysgeusia
|
18.3%
11/60 • Number of events 12 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Headache
|
35.0%
21/60 • Number of events 26 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Nervous system disorders
Neuropathy peripheral
|
11.7%
7/60 • Number of events 7 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Psychiatric disorders
Anxiety
|
8.3%
5/60 • Number of events 5 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Psychiatric disorders
Insomnia
|
8.3%
5/60 • Number of events 6 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Renal and urinary disorders
Proteinuria
|
11.7%
7/60 • Number of events 9 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
10/60 • Number of events 13 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
10/60 • Number of events 13 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.3%
14/60 • Number of events 22 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
5/60 • Number of events 5 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
|
Vascular disorders
Hypertension
|
65.0%
39/60 • Number of events 42 • Adverse events were collected with an onset date on or after the date of first dose of IP and up to and including 30 days following the date of last dose of IP. Assessed until primary analysis DCO (over a period of approximately 2 years and 7 months).
The safety analysis set included all patients who received at least 1 dose of either IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and the PI are entitled to publish the results of or make presentations related to the study, provided that any publication or presentation to be made within 2 years of study completion require the Company's prior written consent. All publications or presentations shall be consistent with academic standards and International Committee of Medical Journal Editors guidelines, not be false or misleading, comply with all Applicable Laws and not be made for any commercial purpose.
- Publication restrictions are in place
Restriction type: OTHER