Trial Outcomes & Findings for A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC) (NCT NCT04765059)
NCT ID: NCT04765059
Last Updated: 2026-01-13
Results Overview
Progression free survival is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for extracranial progression) and Central nervous system (CNS) RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
98 participants
Primary outcome timeframe
From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
Results posted on
2026-01-13
Participant Flow
Participants were enrolled in this study from 12 September 2021 (First participant in) and the analyses presented in this results form are based on a final data cut-off of 28 October 2024.
Participants meeting eligibility criteria predefined in protocol were enrolled in the study. Assessments performed as per the schedule of the assessments.
Participant milestones
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
49
|
49
|
Reasons for withdrawal
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Overall Study
Failure to meet randomization criteria
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Death
|
25
|
28
|
|
Overall Study
Participants ongoing study at data cutoff date of 28-Oct-24
|
21
|
16
|
Baseline Characteristics
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 11.39 • n=210 Participants
|
61.0 Years
STANDARD_DEVIATION 10.02 • n=19 Participants
|
61.5 Years
STANDARD_DEVIATION 10.68 • n=123 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=210 Participants
|
39 Participants
n=19 Participants
|
69 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=210 Participants
|
10 Participants
n=19 Participants
|
29 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=210 Participants
|
7 Participants
n=19 Participants
|
11 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=210 Participants
|
42 Participants
n=19 Participants
|
87 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)Population: The Full analysis set consisted of all randomized participants.
Progression free survival is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for extracranial progression) and Central nervous system (CNS) RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause.
Outcome measures
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
8.4 Months
Interval 5.75 to 11.83
|
4.4 Months
Interval 3.52 to 5.55
|
SECONDARY outcome
Timeframe: Assessed from date of first dose (Day 1) until date of intracranial progression at local site or death due to any cause or data cut off date whichever occurred first (up to 3 years 1 month), data for 6 months reportedPopulation: The Full analysis set consisted of all randomized participants.
Intracranial PFS (IC-PFS) is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause. For participants with brain metastases at baseline, the IC-PFS rate at specified timepoints was estimated using the Kaplan-Meier method which indicated the percentage of these participants who remain alive and free from intracranial progression per CNS RECIST 1.1 as assessed by the Investigator. The data was calculated throughout the study as per the below timeframe but IC-PFS rate at 6 months has been presented as it was clinically relevant.
Outcome measures
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=11 Participants
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=12 Participants
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Intracranial Progression Free Survival With Brain Metastases at Baseline
|
81.8 Percentage of participants
Interval 44.74 to 95.12
|
55.6 Percentage of participants
Interval 20.42 to 80.45
|
SECONDARY outcome
Timeframe: Assessed from date of first dose (Day 1) until date of intracranial progression at local site or death due to any cause or data cut off date whichever occurred first (up to 3 years 1 month), data for 6 months reportedPopulation: The Full analysis set consisted of all randomized participants.
Intracranial PFS (IC-PFS) is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause. For participants without brain metastases at baseline, the IC-PFS rate at specified timepoints was estimated using the Kaplan-Meier method which indicated the percentage of these participants who remain alive and free from intracranial progression per CNS RECIST 1.1 as assessed by the Investigator. The data was calculated throughout the study as per the below timeframe but IC-PFS rate at 6 months has been presented as it was clinically relevant.
Outcome measures
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=38 Participants
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=37 Participants
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Intracranial Progression Free Survival Without Brain Metastases at Baseline
|
86.7 Percentage of participants
Interval 68.08 to 94.83
|
63.1 Percentage of participants
Interval 42.87 to 77.81
|
SECONDARY outcome
Timeframe: From date of first dose (Day 1) until date of extracranial progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)Population: The Full analysis set consisted of all randomized participants.
Extracranial PFS is defined as time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site or death due to any cause.
Outcome measures
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Extracranial Progression Free-survival
|
8.4 Months
Interval 5.75 to 11.83
|
5.2 Months
Interval 3.52 to 5.78
|
SECONDARY outcome
Timeframe: From date of first dose (Day 1) until post progression survival follow-up (up to 3 years 1 month)Population: The Full analysis set consisted of all randomized participants.
Overall survival is defined as the length of time from randomization until the date of death due to any cause.
Outcome measures
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=49 Participants
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Overall Survival (OS)
|
15.9 Months
Interval 12.39 to 20.83
|
9.8 Months
Interval 8.38 to 17.25
|
Adverse Events
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
Serious events: 18 serious events
Other events: 46 other events
Deaths: 26 deaths
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
Serious events: 15 serious events
Other events: 47 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=48 participants at risk
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=48 participants at risk
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Cellulitis
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Device related infection
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Sepsis
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Ischaemic stroke
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Right hemisphere deficit syndrome
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Eye disorders
Diplopia
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Volvulus
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
General disorders
Asthenia
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
General disorders
Non-cardiac chest pain
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
General disorders
Pyrexia
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Platelet count decreased
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
Other adverse events
| Measure |
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=48 participants at risk
Participants received osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin
n=48 participants at risk
Participants received placebo QD with pemetrexed (500 mg/m2) (with pre-treatment) plus either cisplatin (75 mg/m2) or carboplatin, both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m2) on Day 1 of 21-day cycles.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Conjunctivitis
|
14.6%
7/48 • Number of events 7 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
COVID-19
|
12.5%
6/48 • Number of events 6 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Paronychia
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
4/48 • Number of events 5 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Anaemia
|
62.5%
30/48 • Number of events 64 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
54.2%
26/48 • Number of events 44 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
3/48 • Number of events 7 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 8 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.8%
10/48 • Number of events 22 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
18.8%
9/48 • Number of events 12 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
4/48 • Number of events 11 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
8/48 • Number of events 16 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
18.8%
9/48 • Number of events 11 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemi
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 8 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Headache
|
8.3%
4/48 • Number of events 5 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
14.6%
7/48 • Number of events 7 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
12.5%
6/48 • Number of events 8 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
5/48 • Number of events 5 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
2/48 • Number of events 6 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 6 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Constipation
|
22.9%
11/48 • Number of events 12 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
22.9%
11/48 • Number of events 13 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
15/48 • Number of events 19 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
10.4%
5/48 • Number of events 6 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Nausea
|
35.4%
17/48 • Number of events 37 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
47.9%
23/48 • Number of events 43 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Stomatitis
|
10.4%
5/48 • Number of events 8 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Gastrointestinal disorders
Vomiting
|
27.1%
13/48 • Number of events 18 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
18.8%
9/48 • Number of events 24 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.2%
3/48 • Number of events 6 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
0.00%
0/48 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.4%
5/48 • Number of events 6 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
10.4%
5/48 • Number of events 8 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
2/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
4/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
4.2%
2/48 • Number of events 9 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Renal and urinary disorders
Dysuria
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
General disorders
Asthenia
|
39.6%
19/48 • Number of events 40 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
47.9%
23/48 • Number of events 40 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
General disorders
Fatigue
|
10.4%
5/48 • Number of events 12 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
General disorders
Oedema peripheral
|
12.5%
6/48 • Number of events 8 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 7 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
General disorders
Pyrexia
|
12.5%
6/48 • Number of events 7 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
6.2%
3/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
8/48 • Number of events 13 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
18.8%
9/48 • Number of events 15 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Aspartate aminotransferase increased
|
14.6%
7/48 • Number of events 10 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
14.6%
7/48 • Number of events 14 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.1%
1/48 • Number of events 2 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
10.4%
5/48 • Number of events 6 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Blood creatinine increased
|
16.7%
8/48 • Number of events 13 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 7 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.1%
1/48 • Number of events 1 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 5 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.2%
3/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
10.4%
5/48 • Number of events 7 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Lymphocyte count decreased
|
4.2%
2/48 • Number of events 4 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
8.3%
4/48 • Number of events 8 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Neutrophil count decreased
|
18.8%
9/48 • Number of events 39 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
25.0%
12/48 • Number of events 22 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
Platelet count decreased
|
20.8%
10/48 • Number of events 21 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
4.2%
2/48 • Number of events 3 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
|
Investigations
White blood cell count decreased
|
12.5%
6/48 • Number of events 31 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
16.7%
8/48 • Number of events 16 • From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)
The safety analysis set consisted of all randomized participants who had received at least 1 dose of IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB.
- Publication restrictions are in place
Restriction type: OTHER