NCT01774721 · OUTCOME
Number of Participants With Clinically Significant Abnormalities in Vital Signs
ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. · Source last updated 2023-11-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization until death or last date known as alive, up to 61 months
What was measured
Criteria for vital signs abnormalities: postbaseline pulse rate less than (\<) 50 beats per minute (bpm) or greater than (\>)130 bpm and maximum increase from baseline in pulse rate \>=30 bpm and maximum decrease from baseline in pulse rate \<=30 bpm. Systolic blood pressure (BP) of maximum increase from baseline (MIB) \>=40 millimeters of mercury (mmHg), maximum decrease from baseline (MDB) in systolic blood pressure =\<60 mmHg. Diastolic blood pressure of MIB \>=20 mmHg and MDB in diastolic blood pressure \>-40 and =\<-20 mm Hg. And MDB in diastolic BP\<=-40 mmHg. Only categories with at least 1 participant with abnormality are reported in this outcome measure.
Analysis population: Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
Groups in this outcome
Dacomitinib
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Gefitinib
Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
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 |
|---|
| Dacomitinib | 227 |
|---|
| Gefitinib | 224 |
|---|
Reported measurements
MIB in systolic BP >=40 mmHg
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 224 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
MDB in systolic BP <=-60 mmHg
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 224 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
MIB in diastolic BP >=20 mmHg
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 224 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
MDB in diastolic BP >-40 and <=-20mmHg
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 224 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
MDB in diastolic BP <=-40 mmHg
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 224 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Maximum post baseline pulse rate >130 bpm
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 226 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimum post baseline pulse rate <50 bpm
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 226 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
MIB in pulse rate >=30 bpm
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 225 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
MDB in pulse rate <=-30 bpm
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 225 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
MIB in body weight >=10%
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 225 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
MDB in body weight <=-10%
Analysis denominator · Participants
| Group | Source count |
|---|
| Dacomitinib | 225 |
|---|
| Gefitinib | 223 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Dacomitinib | 46 | Not reported | Not reported | Not reported | Not reported |
|---|
| Gefitinib | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MIB in systolic BP >=40 mmHg
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MDB in systolic BP <=-60 mmHg
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 44
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MIB in diastolic BP >=20 mmHg
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 53
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MDB in diastolic BP >-40 and <=-20mmHg
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MDB in diastolic BP <=-40 mmHg
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- Maximum post baseline pulse rate >130 bpm
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- Minimum post baseline pulse rate <50 bpm
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 225
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MIB in pulse rate >=30 bpm
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 15
- denoms
- counts
- group Id
- OG000
- value
- 225
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MDB in pulse rate <=-30 bpm
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 42
- denoms
- counts
- group Id
- OG000
- value
- 225
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MIB in body weight >=10%
- categories
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 32
- denoms
- counts
- group Id
- OG000
- value
- 225
- group Id
- OG001
- value
- 223
- units
- Participants
- title
- MDB in body weight <=-10%
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 224
- units
- Participants
- description
- Criteria for vital signs abnormalities: postbaseline pulse rate less than (\<) 50 beats per minute (bpm) or greater than (\>)130 bpm and maximum increase from baseline in pulse rate \>=30 bpm and maximum decrease from baseline in pulse rate \<=30 bpm. Systolic blood pressure (BP) of maximum increase from baseline (MIB) \>=40 millimeters of mercury (mmHg), maximum decrease from baseline (MDB) in systolic blood pressure =\<60 mmHg. Diastolic blood pressure of MIB \>=20 mmHg and MDB in diastolic blood pressure \>-40 and =\<-20 mm Hg. And MDB in diastolic BP\<=-40 mmHg. Only categories with at least 1 participant with abnormality are reported in this outcome measure.
- groups
- description
- Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
- id
- OG000
- title
- Dacomitinib
- description
- Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
- id
- OG001
- title
- Gefitinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
- reporting Status
- POSTED
- time Frame
- From randomization until death or last date known as alive, up to 61 months
- title
- Number of Participants With Clinically Significant Abnormalities in Vital Signs
- type
- SECONDARY
- unit Of Measure
- Participants
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