Trial Outcomes & Findings for Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (NCT NCT05694013)
NCT ID: NCT05694013
Last Updated: 2025-10-22
Results Overview
The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
49 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2025-10-22
Participant Flow
Participants with extensive- stage small-cell lung carcinoma (ES-SCLC) or hepatocellular carcinoma (HCC) or non-small cell lung carcinoma (NSCLC) that are prescribed a locally-approved anti-cancer regimen containing IV atezolizumab.
Participant milestones
| Measure |
Atezolizumab Regimen
Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
22
|
21
|
Reasons for withdrawal
| Measure |
Atezolizumab Regimen
Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Overall Study
Death
|
6
|
2
|
|
Overall Study
Participant Decision
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Progressive Disease
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
12
|
17
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice
Baseline characteristics by cohort
| Measure |
Atezolizumab Regimen
n=25 Participants
Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=24 Participants
Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
62.0 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The ITT population included all randomized participants.
The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life.
Outcome measures
| Measure |
Atezolizumab Regimen
n=25 Participants
Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=24 Participants
Participants with mNSCLC, ES-SCLC, and HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Mean Difference in Change of Week 12 Value From Baseline of Participant-reported Total Symptom Interference Score From the MD Anderson Symptom Inventory (MDASI) Core Items
Baseline
|
3.33 Units on a scale
Interval 0.0 to 9.8
|
3.08 Units on a scale
Interval 0.0 to 9.5
|
|
Mean Difference in Change of Week 12 Value From Baseline of Participant-reported Total Symptom Interference Score From the MD Anderson Symptom Inventory (MDASI) Core Items
Cycle 5 Day 1 (Week 12)
|
3.00 Units on a scale
Interval 0.0 to 9.0
|
2.33 Units on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days)Population: The ITT population included all randomized participants.
The European Organisation for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The EORTC item library 6 (IL6) GHS/QoL consists of only the GHS and QoL items from the EORTC QLQ-C30. The raw score is calculated as the value of both answers, scored on a 7-point scale that ranges from 1 ("very poor") to 7 ("excellent"), then a linear transformation is applied to produce a score between 0-100. Higher scores indicate a higher QoL.
Outcome measures
| Measure |
Atezolizumab Regimen
n=25 Participants
Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=24 Participants
Participants with mNSCLC, ES-SCLC, and HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Change From Baseline in Global Health Status Score/Quality of Life Score (GHS/QoL) From the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL
Baseline
|
66.67 Units on a scale
Interval 16.7 to 100.0
|
66.67 Units on a scale
Interval 33.3 to 100.0
|
|
Change From Baseline in Global Health Status Score/Quality of Life Score (GHS/QoL) From the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL
Cycle 3 Day 1
|
66.67 Units on a scale
Interval 16.7 to 100.0
|
58.33 Units on a scale
Interval 0.0 to 100.0
|
|
Change From Baseline in Global Health Status Score/Quality of Life Score (GHS/QoL) From the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL
Cycle 5 Day 1
|
62.50 Units on a scale
Interval 50.0 to 100.0
|
70.83 Units on a scale
Interval 41.7 to 100.0
|
|
Change From Baseline in Global Health Status Score/Quality of Life Score (GHS/QoL) From the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL
Cycle 7 Day 1
|
66.67 Units on a scale
Interval 25.0 to 100.0
|
83.33 Units on a scale
Interval 41.7 to 100.0
|
|
Change From Baseline in Global Health Status Score/Quality of Life Score (GHS/QoL) From the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL
Cycle 9 Day 1
|
62.50 Units on a scale
Interval 50.0 to 100.0
|
83.33 Units on a scale
Interval 66.7 to 91.7
|
|
Change From Baseline in Global Health Status Score/Quality of Life Score (GHS/QoL) From the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL
Long Term Follow Up (Week 28)
|
75.00 Units on a scale
Interval 50.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days)Population: The ITT population consisted of all randomized participants.
The EQ-5D-5L is used to calculate a health status utility score for use in health economic analyses. The questionnaire is designed to capture the participant's current health status. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The score range is 0-100, with higher scores indicating better outcomes.
Outcome measures
| Measure |
Atezolizumab Regimen
n=25 Participants
Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=24 Participants
Participants with mNSCLC, ES-SCLC, and HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument
Cycle 5 Day 1
|
78.00 Units on a scale
Interval 3.0 to 100.0
|
85.00 Units on a scale
Interval 37.0 to 100.0
|
|
Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument
Baseline
|
71.00 Units on a scale
Interval 0.0 to 100.0
|
83.50 Units on a scale
Interval 31.0 to 100.0
|
|
Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument
Cycle 3 Day 1
|
65.00 Units on a scale
Interval 2.0 to 96.0
|
59.00 Units on a scale
Interval 20.0 to 100.0
|
|
Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument
Cycle 7 Day 1
|
67.50 Units on a scale
Interval 32.0 to 99.0
|
65.00 Units on a scale
Interval 21.0 to 97.0
|
|
Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument
Cycle 9 Day 1
|
67.50 Units on a scale
Interval 59.0 to 100.0
|
90.00 Units on a scale
Interval 49.0 to 94.0
|
|
Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument
Long Term Follow Up (Week 28)
|
70.00 Units on a scale
Interval 40.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days)Population: The ITT population consisted of all randomized participants.
The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life.
Outcome measures
| Measure |
Atezolizumab Regimen
n=25 Participants
Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=24 Participants
Participants with mNSCLC, ES-SCLC, and HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items
Baseline
|
3.33 Units on a scale
Interval 0.0 to 9.8
|
3.08 Units on a scale
Interval 0.0 to 9.5
|
|
Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items
Cycle 3 Day 1
|
2.67 Units on a scale
Interval 0.0 to 9.2
|
3.00 Units on a scale
Interval 0.0 to 8.0
|
|
Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items
Cycle 5 Day 1
|
3.00 Units on a scale
Interval 0.0 to 9.0
|
2.33 Units on a scale
Interval 0.0 to 7.0
|
|
Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items
Cycle 7 Day 1
|
1.50 Units on a scale
Interval 0.0 to 7.2
|
3.17 Units on a scale
Interval 0.0 to 5.8
|
|
Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items
Cycle 9 Day 1
|
1.67 Units on a scale
Interval 0.0 to 5.0
|
1.17 Units on a scale
Interval 0.0 to 6.3
|
|
Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items
Long Term Follow Up (Week 28)
|
3.42 Units on a scale
Interval 0.0 to 6.8
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 16 monthsPopulation: The ITT population consisted of all randomized participants.
Outcome measures
| Measure |
Atezolizumab Regimen
n=7 Participants
Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=12 Participants
Participants with mNSCLC, ES-SCLC, and HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Number of Cumulative Days Hospitalized Due to SAEs
|
11.0 Days
Interval 4.0 to 30.0
|
4.0 Days
Interval 3.0 to 46.0
|
Adverse Events
Atezolizumab Regimen
Serious events: 10 serious events
Other events: 18 other events
Deaths: 6 deaths
Atezolizumab Regimen + DPM
Serious events: 13 serious events
Other events: 22 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Atezolizumab Regimen
n=25 participants at risk
Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=24 participants at risk
Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
General disorders
Chest pain
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
General disorders
Pyrexia
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Infections and infestations
COVID-19
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Investigations
C-reactive protein increased
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Nervous system disorders
Aphasia
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.0%
2/25 • Number of events 2 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/25 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Vascular disorders
Thrombosis
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
Other adverse events
| Measure |
Atezolizumab Regimen
n=25 participants at risk
Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support.
|
Atezolizumab Regimen + DPM
n=24 participants at risk
Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
5/25 • Number of events 6 • Up to approximately 16 months
|
25.0%
6/24 • Number of events 8 • Up to approximately 16 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 4 • Up to approximately 16 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Number of events 2 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 3 • Up to approximately 16 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/25 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/25 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
5/25 • Number of events 6 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/25 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • Number of events 3 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
4/25 • Number of events 5 • Up to approximately 16 months
|
20.8%
5/24 • Number of events 5 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • Number of events 4 • Up to approximately 16 months
|
29.2%
7/24 • Number of events 9 • Up to approximately 16 months
|
|
General disorders
Asthenia
|
20.0%
5/25 • Number of events 5 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 2 • Up to approximately 16 months
|
29.2%
7/24 • Number of events 8 • Up to approximately 16 months
|
|
General disorders
Mucosal inflammation
|
12.0%
3/25 • Number of events 3 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
General disorders
Oedema peripheral
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
General disorders
Pyrexia
|
0.00%
0/25 • Up to approximately 16 months
|
16.7%
4/24 • Number of events 4 • Up to approximately 16 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/25 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Infections and infestations
Respiratory tract infection
|
8.0%
2/25 • Number of events 2 • Up to approximately 16 months
|
0.00%
0/24 • Up to approximately 16 months
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • Number of events 2 • Up to approximately 16 months
|
4.2%
1/24 • Number of events 1 • Up to approximately 16 months
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 4 • Up to approximately 16 months
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/25 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Investigations
Weight decreased
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
5/25 • Number of events 5 • Up to approximately 16 months
|
20.8%
5/24 • Number of events 5 • Up to approximately 16 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/25 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/25 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 5 • Up to approximately 16 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Number of events 2 • Up to approximately 16 months
|
16.7%
4/24 • Number of events 6 • Up to approximately 16 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
16.7%
4/24 • Number of events 4 • Up to approximately 16 months
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
2/25 • Number of events 2 • Up to approximately 16 months
|
8.3%
2/24 • Number of events 2 • Up to approximately 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25 • Number of events 3 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • Number of events 2 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25 • Number of events 1 • Up to approximately 16 months
|
12.5%
3/24 • Number of events 3 • Up to approximately 16 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
3/25 • Number of events 4 • Up to approximately 16 months
|
20.8%
5/24 • Number of events 5 • Up to approximately 16 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • Up to approximately 16 months
|
16.7%
4/24 • Number of events 4 • Up to approximately 16 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER