NCT03456076 · OUTCOME
Percentage of Participants With Adverse Events (AEs)
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer · Source last updated 2026-07-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
What was measured
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Analysis population: The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.
Groups in this outcome
Alectinib
Participants received 600 mg oral alectinib twice daily (BID) for 2 years
Platinum-Based Chemotherapy
Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Alectinib | 128 |
|---|
| Platinum-Based Chemotherapy | 120 |
|---|
Reported measurements
At least one AE
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 98.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 93.3 | Not reported | Not reported | Not reported | Not reported |
|---|
AE with fatal outcome
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3-5 AE
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 29.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 30.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious AE (SAE)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 13.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 8.3 | Not reported | Not reported | Not reported | Not reported |
|---|
SAE leading to treatment withdrawal
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 0.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 3.3 | Not reported | Not reported | Not reported | Not reported |
|---|
SAE leading to dose modification/interruption
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 5.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 3.3 | Not reported | Not reported | Not reported | Not reported |
|---|
Related SAE
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 1.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 6.7 | Not reported | Not reported | Not reported | Not reported |
|---|
AE leading to treatment withdrawal
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 5.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 12.5 | Not reported | Not reported | Not reported | Not reported |
|---|
AE leading to dose modification/interruption
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 43.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 22.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Related AE
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 93.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 89.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Related AE leading to treatment withdrawal
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 5.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 11.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Related AE leading to dose mod./interruption
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Alectinib | 38.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Platinum-Based Chemotherapy | 21.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 98.4
- group Id
- OG001
- value
- 93.3
- title
- At least one AE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- AE with fatal outcome
- categories
- measurements
- group Id
- OG000
- value
- 29.7
- group Id
- OG001
- value
- 30.8
- title
- Grade 3-5 AE
- categories
- measurements
- group Id
- OG000
- value
- 13.3
- group Id
- OG001
- value
- 8.3
- title
- Serious AE (SAE)
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 3.3
- title
- SAE leading to treatment withdrawal
- categories
- measurements
- group Id
- OG000
- value
- 5.5
- group Id
- OG001
- value
- 3.3
- title
- SAE leading to dose modification/interruption
- categories
- measurements
- group Id
- OG000
- value
- 1.6
- group Id
- OG001
- value
- 6.7
- title
- Related SAE
- categories
- measurements
- group Id
- OG000
- value
- 5.5
- group Id
- OG001
- value
- 12.5
- title
- AE leading to treatment withdrawal
- categories
- measurements
- group Id
- OG000
- value
- 43.0
- group Id
- OG001
- value
- 22.5
- title
- AE leading to dose modification/interruption
- categories
- measurements
- group Id
- OG000
- value
- 93.8
- group Id
- OG001
- value
- 89.2
- title
- Related AE
- categories
- measurements
- group Id
- OG000
- value
- 5.5
- group Id
- OG001
- value
- 11.7
- title
- Related AE leading to treatment withdrawal
- categories
- measurements
- group Id
- OG000
- value
- 38.3
- group Id
- OG001
- value
- 21.7
- title
- Related AE leading to dose mod./interruption
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 120
- units
- Participants
- description
- An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
- groups
- description
- Participants received 600 mg oral alectinib twice daily (BID) for 2 years
- id
- OG000
- title
- Alectinib
- description
- Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
- id
- OG001
- title
- Platinum-Based Chemotherapy
- param Type
- NUMBER
- population Description
- The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.
- reporting Status
- POSTED
- time Frame
- Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
- title
- Percentage of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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